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Articles by Category - FDA

2009 | 2008 | 2007 | 2006 | 2005 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | 1994 | 1993 | 1992 | 1991 | 1990 | 1989 | 1988 | 1987 | 1986 | 1985 | 1984 | 1983 | 1982 | 1981 | 1980 | 1979

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2009

• (Washington Wrap-Up) CDRH Practices Finally Get Attention in 510(k) Probe, James G. Dickinson (MDDI, Jul 2009, p. 26).
• (Washington Wrap-Up) Congress May Hit Device Makers with a Triple Whammy, James G. Dickinson (MDDI, Mar 2009, p. 26). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) How Does a Weapon Almost Become a Medical Device?, James G. Dickinson (MDDI, Feb 2009, p. 26). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Could New Administration Freeze Out Industry Access?, James G. Dickinson (MDDI, Jan 2009, p. 30). Keywords: Regulatory Affairs.

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2008

• (Washington Wrap-Up) 2008: High and Low Notes for FDA Enforcers, Budgeteers, James G. Dickinson (MDDI, Dec 2008, p. 18). Keywords: Regulatory Affairs.
• (From the Editors) Be Ready for a New, More Selective Era for Investment, Sherrie Conroy (MDDI, Dec 2008, p. 14).
• (Washington Wrap-Up) CDRH Weaves ‘Tangled Web’ on LASIK, James G. Dickinson (MDDI, Nov 2008, p. 22).
• (From the Editors) So Far, So Good for FDAAA, Erik Swain (MDDI, Nov 2008, p. 14).
• (Washington Wrap-Up) Senators Pick Up Preemption Rollback, James G. Dickinson (MDDI, Oct 2008, p. 24).
• (NewsTrends) Hospital Investment in RFID Seeing Rapid Increase, Maria Fontanazza (MDDI, Sep 2008, p. 20).
• (NewsTrends) GPO Forges Ahead with Device Identification Standards, Maria Fontanazza (MDDI, Sep 2008, p. 20).
• (Washington Wrap-Up) Does FDA Know Its Litigation Expenses?, James G. Dickinson (MDDI, Sep 2008, p. 34).
• (NewsTrends) Bill Would Allow PMA Holders to Be Sued in State Courts, Erik Swain (MDDI, Aug 2008, p. 22).
• (Washington Wrap-Up) CDRH Changes Tune on Dental Mercury, James G. Dickinson (MDDI, Aug 2008, p. 34). Keywords: Regulatory Affairs.
• (NewsTrends) Database System to Boost FDA’s Postmarket Surveillance Capability, Erik Swain (MDDI, Jul 2008, p. 18).
• (Washington Wrap-Up) An Honest Assessment May Boost FDA Appropriation, James G. Dickinson (MDDI, Jul 2008, p. 24). Keywords: Regulatory Affairs.
• (From the Editors) Be Prepared: Software Forensics Gaining Steam at FDA, Sherrie Conroy (MDDI, Jul 2008, p. 14). Keywords: Software Forensics.
• (NewsTrends) Congress Seeks Tighter FDA Regulation of Foreign Imports and Inspections, Maria Fontanazza (MDDI, Jun 2008, p. 18).
• (Washington Wrap-Up) Republicans Press FDA on Device Appeals, James G. Dickinson (MDDI, Jun 2008, p. 28).
• (Washington Wrap-Up) FDA Placing Its Own Personnel in China, James G. Dickinson (MDDI, May 2008, p. 34).
• (Washington Wrap-Up) Ignoring an Inconvenient Truth, James G. Dickinson (MDDI, Apr 2008, p. 30).
• (Washington Wrap-Up) Do FDA Chiefs Have Real Power?, James G. Dickinson (MDDI, Mar 2008, p. 38). Keywords: Regulatory Affairs.
• (From the Editors) FDA Needs More Money and More Ideas, Erik Swain (MDDI, Mar 2008, p. 16). Keyword: Diagnostics.
• (NewsTrends) Lack of Resources Compromises Product Safety, Maria Fontanazza (MDDI, Feb 2008, p. 24).
• (Washington Wrap-Up) CDRH Promises Punishment, James G. Dickinson (MDDI, Feb 2008, p. 30).
• (NewsTrends) CDRH Seeks Industry’s Input on Guidance, Lawrence Lloyd (MDDI, Jan 2008, p. 24).
• (NewsTrends) Device Advocates Assert FDA’s Authority, Maria Fontanazza (MDDI, Jan 2008, p. 24).
• (Washington Wrap-Up) A Web of Conflicts of Interest, James G. Dickinson (MDDI, Jan 2008, p. 36).

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2007

• (Washington Wrap-Up) 2007: The Year of FDA’s Transformation, James G. Dickinson (MDDI, Dec 2007, p. 18). Keywords: Regulatory Affairs.
• (From the Editors) No Conflicts? Not Possible, Sherrie Conroy (MDDI, Dec 2007, p. 14). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) In Pursuing an ICD Case, States Outperform FDA, James G. Dickinson (MDDI, Nov 2007, p. 32). Keywords: Regulatory Affairs.
• (NewsTrends) FDA and DoD to Share Device Data, Maria Fontanazza (MDDI, Oct 2007, p. 20).
• (NewsTrends) FDA Field Labs Remain Open (For Now), Maria Fontanazza (MDDI, Oct 2007, p. 20).
• (NewsTrends) As FDA Remains Mum on Stent Probe, Market Decline Continues, Maria Fontanazza (MDDI, Oct 2007, p. 20).
• (Washington Wrap-Up) FDA Ombudsman Shows Resolve, James G. Dickinson (MDDI, Oct 2007, p. 34). Keywords: Regulatory Affairs.
• (From the Editors) Bill Saves FDA Jobs, But Could Hide a Few Land Mines, Sherrie Conroy (MDDI, Oct 2007, p. 14). Keyword: Government.
• (NewsTrends) Groups Petition FDA to Require DEHP Labeling on Devices, Maria Fontanazza (MDDI, Sep 2007, p. 20).
• (NewsTrends) Report Calls for FDA Nanotech Guidance, Erik Swain (MDDI, Sep 2007, p. 20).
• (Washington Wrap-Up) FDA House Judge Rules against TMJ Implants, James G. Dickinson (MDDI, Sep 2007, p. 34).
• (Q&A) Money for FDA’s Mission, Erik Swain (MDDI, Aug 2007, p. 62).
• (Regulatory Outlook) How to Manage an FDA Inspection, Mary Armstrong (MDDI, Aug 2007, p. 54).
• (Washington Wrap-Up) Something Rotten in the State of FDA, James G. Dickinson (MDDI, Aug 2007, p. 38).
• (From the Editors) Expertise Has Its Price, Erik Swain (MDDI, Aug 2007, p. 14).
• (NewsTrends) AdvaMed and FDA Review MDR Timing, Erik Swain (MDDI, Aug 2007, p. 22).
• (NewsTrends) FDA Forms Risk-Communication Panel, The Editors (MDDI, Aug 2007, p. 22).
• (NewsTrends) FDA Review and Approval Not Fast Enough, Poll Finds, Maria Fontanazza (MDDI, Aug 2007, p. 22).
• (NewsTrends) FDA Moving Forward with Postmarket Safety Network, Maria Fontanazza (MDDI, Jul 2007, p. 22).
• (Washington Wrap-Up) User Fees to Pay for Postmarket Surveillance?, James G. Dickinson (MDDI, Jul 2007, p. 36). Keywords: Regulatory Affairs.
• (From the Editors) Are You Ready for a New FDA?, Sherrie Conroy (MDDI, May 2007, p. 14). Keyword: Industry.
• (From the Editors) Off-Label Promotion: The Game Is Up, Erik Swain (MDDI, Apr 2007, p. 14). Keyword: Industry.
• "(Conference News: MD&M Minneapolis) Accelerated Aging Key to Understanding Package Failure, but Real-Time Data Needed Also", Stephanie Steward (MDDI, Jan 2007, p. 32).
• (Conference News: MD&M Minneapolis) Cover All the Bases When Filing for a Medical Device Patent, Maria Fontanazza (MDDI, Jan 2007, p. 32).
• (Conference News: MD&M Minneapolis) Managing Device Changes Streamlines Product Development, Sherrie Conroy (MDDI, Jan 2007, p. 32).
• (Conference News: MD&M Minneapolis) Using FDA’s Guidelines Can Help Avoid Problems with Promotions, Heather Thompson (MDDI, Jan 2007, p. 32).
• (NewsTrends) New England Companies Awarded for Innovation, Maria Fontanazza (MDDI, Jan 2007, p. 24).
• (NewsTrends) Colorado Incubator Site Warms to Medical Device Entrepreneurs, Heather Thompson (MDDI, Jan 2007, p. 24).
• "(NewsTrends) FDA, Health Canada Agree to Joint Inspection Program", Maria Fontanazza (MDDI, Jan 2007, p. 24).
• (NewsTrends) Reforms Should Strengthen CDRH Postmarket Surveillance, Erik Swain (MDDI, Jan 2007, p. 24).
• (Washington Wrap-Up) Will the Democrats’ New Broom Sweep CDRH?, The Editors (MDDI, Jan 2007, p. 44).

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2006

• (Washington Wrap-Up) Product Safety, User Fees Top Issues in 2006, James G. Dickinson (MDDI, Dec 2006, p. 20). Keywords: Regulatory Affairs.
• (Q & A) Scrutinizing the Scrutinizers, Erik Swain (MDDI, Oct 2006, p. 74). Keyword: QSIT.
• (First Person) The Utah Medical Case Does Make a Difference, Larry R. Pilot (MDDI, Oct 2006, p. 68). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Utah Medical Presses Its Fight with FDA, James G. Dickinson (MDDI, Oct 2006, p. 48). Keywords: Regulatory Affairs.
• (From the Editors) McClellan Leaves CMS, Industry Loses a Friend, Sherrie Conroy (MDDI, Oct 2006, p. 14). Keywords: Regulatory Affairs.
• (NewsTrends) FDA Aims to Modernize Clinical Trial Regulations, Erik Swain (MDDI, Aug 2006, p. 24). Keywords: New Technologies.
• (Washington Wrap-Up) FDA as Product Development Facilitator, James G. Dickinson (MDDI, Aug 2006, p. 42). Keywords: Regulatory Affairs.
• (From the Editors) FDA Tightens Reins on Advisory Committee Process, Sherrie Conroy (MDDI, Aug 2006, p. 14). Keywords: Regulatory Affairs.
• (NewsTrends) CDRH Unveils Sweeping Plan to Promote Innovation, Erik Swain (MDDI, Jul 2006, p. 26). Keyword: Industry.
• (NewsTrends) CDRH Adds 510(k) Goal to MDUFMA Efforts, Erik Swain (MDDI, Jul 2006, p. 26). Keyword: MDUFMA.
• (From the Editors) To Regulate or Facilitate?, Erik Swain (MDDI, Jul 2006, p. 14). Keywords: Regulatory Affairs.
• (From the Editors) FDA: A New Program for Improving Postmarket Safety, Sherrie Conroy (MDDI, Feb 2006, p. 16). Keyword: Standards.
• (Human Factors) Fitting Human Factors in the Product Development Process, Patricia A. Patterson and Robert A. North (MDDI, Jan 2006, p. 124). Keyword: Manufacturing.
• (From the Editors) The Unintended Consequences of Meeting MDUFMA Goals, Erik Swain (MDDI, Jan 2006, p. 16). Keyword: Industry.

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2005

• (Washington Wrap-Up) FDA Enforcement Actions Loomed Large in 2005, James G. Dickinson (MDDI, Dec 2005, p. 22). Keywords: Regulatory Affairs.
• (WASHINGTON WRAP-UP) FDA Plans to Force Postapproval Studies through Public Exposure, James G. Dickinson (MDDI, Nov 2005, p. 32). Keywords: Regulatory Affairs.
• (From the Editors) Political Fallout Knows No Bounds, The Editors (MDDI, Nov 2005, p. 14). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Company Secrets at Risk in FDA, James G. Dickinson (MDDI, Oct 2005, p. 44). Keywords: New Technology.
• (WASHINGTON WRAP-UP) FDA Reorganizes Its Inspection Command, James G. Dickinson (MDDI, Sep 2005, p. 40). Keywords: Legal Affairs.
• (Newstrends) MedSun Shifts Focus to Improved Reporting, Maria Fontanazza (MDDI, Sep 2005, p. 20). Keywords: New Technologies.
• (Newstrends) FDA to Emphasize Human Factors, Erik Swain (MDDI, Sep 2005, p. 20). Keywords: Human Factors.
• (Q&A) The Modernization of ODE, The Editors (MDDI, Aug 2005, p. 68). Keyword: Industry.
• (Washington Wrap Up) Can product recalls be a good thing?, James G. Dickson (MDDI, Aug 2005, p. 40). Keywords: Regulatory Affairs.
• (Newstrends) Senate confirms Crawford, at last, The Editors (MDDI, Aug 2005, p. 28). Keyword: Industry.
• (Newstrends) Ready for action: War room strategy for FDA inspection, Erik Swain (MDDI, Aug 2005, p. 23). Keywords: Facility Inspection.
• (Newstrends) Guidant recalls may be industry wake-up call, Maria Fontanazza (MDDI, Aug 2005, p. 22). Keyword: Industry.
• (Newstrends) CDRH Steps Up Tracking of Postmarket Studies, Maria Fontanazza (MDDI, Jul 2005, p. 24). Keyword: Industry.
• (Regulatory Outlook) How to Avoid an MDR Disaster: Set Up An Effective Reporting System, Pamela J Furman (MDDI, Jun 2005, p. 50). Keyword: Industry.
• (Newstrends) SOPs Can Ease the Pain of a Recall, Erin Bradford (MDDI, Jun 2005, p. 25). Keyword: Recalls.
• (Newstrends) No Consensus Near on Coding Mandate for Devices, Erik Swain (MDDI, Jun 2005, p. 23). Keywords: Coding Mandate.

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2002

• (News and Analysis) New Law Accelerates FDA's Combination Product Reform, John Bethune (MDDI, Dec 2002, p. 18). Keywords: Regulatory Affairs.
• (News & Analysis) FDA Tightens Screws on DEHP Use, Robert Drummond (MDDI, Nov 2002, p. 18). Keyword: Materials.
• (Editor's Page) Follow the Money: Economics Infiltrates FDA (MDDI, Nov 2002, p. 12). Keyword: Industry.
• (Washington Wrap-Up) Congress Enacts Device Law and Confirms FDA Chief, James Dickinson (MDDI, Nov 2002, p. 24). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) FDA's Statland Leaves Lasting Mark, James Dickinson (MDDI, Oct 2002, p. 38). Keywords: Regulatory Affairs.
• (News & Analysis) Agency Calls for Comments on Opened-But-Unused Single-Use Devices (MDDI, Sep 2002, p. 20).
• (News & Analysis) Document Offers Guidance on Resorbable Adhesion Barriers, Jim Dickinson (MDDI, Sep 2002, p. 20). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Battle Brewing Over Third-Party Inspections, James Dickinson (MDDI, Sep 2002, p. 30). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) FDA's Feigal Raps Industry on Quality, James Dickinson (MDDI, Aug 2002, p. 32). Keywords: Regulatory Affairs.
• (Editor's Page) waiting for nano: How Long Will Molecular-Scale Devices Remain Science Fiction? (MDDI, Jul 2002, p. 12).
• (Washington Wrap-Up) International Medical Tries to Avoid a Consent Decree, James Dickinson (MDDI, Jul 2002, p. 38). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Device Experiences Database Updated, James Dickinson (MDDI, Jul 2002, p. 38). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Abbott Fails FDA Inspection, James Dickinson (MDDI, Jul 2002, p. 36). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) FDA Cuts Warning Letters by 70%, James Dickinson (MDDI, Jul 2002, p. 36). Keywords: Regulatory Affairs.
• (Editor's Page) As Inspections Dwindle, Will a Crisis Grow? (MDDI, Jun 2002, p. 12).
• (Washington Wrap-Up) Software-powered cleaning technology catches FDA’s eye, James Dickinson (MDDI, Jun 2002, p. 30). Keywords: Regulatory Affairs.
• (Editor's Page) As Inspections Dwindle, Will a Crisis Grow? (MDDI, May 2002, p. 12).
• (Washington Wrap-Up) Jim Benson Remembers When FDA Wasn't Talking, James Dickinson (MDDI, May 2002, p. 43). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Abbott reinspection raises old issues, new questions, James Dickinson (MDDI, Apr 2002, p. 32). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Thompson tries stanching FDA's information flow, James Dickinson (MDDI, Mar 2002, p. 32). Keywords: Regulatory Affairs.
• (Help Desk) Avoiding Warning Letters, John Lincoln (MDDI, Feb 2002, p. 20). Keyword: Industry.
• (News & Analysis) FDA Notice (MDDI, Feb 2002, p. 28).
• (News & Analysis) Decade-Old EMC Standard Updated, William Leventon (MDDI, Feb 2002, p. 15). Keyword: Industry.
• (Editor's Page) Waiting for a Commissioner: Bureaucratic Delay or a Fresh Start? (MDDI, Feb 2002, p. 14). Keyword: Regulatory.
• (Washington Wrap-Up) Putting teeth into FDA warning letters, James Dickinson (MDDI, Feb 2002, p. 30). Keyword: Industry.

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2001

• (First Person) Looking toward a new medical technology policy, Joshua Adler (MDDI, Oct 2001, p. 72).
• (Washington Wrap-Up) Bush taming FDA? Some think not, James Dickinson (MDDI, Oct 2001, p. 48).
• Answering the Call for Harmonization of Medical Device Alarms, Michael Wiklund (MDDI, Oct 2001, p. 118). Keyword: Standards.
• (Washington Wrap-Up) Agency's 510(k) rescission plan criticized, James Dickinson (MDDI, Sep 2001, p. 40).
• (Editor's Page) Software regulation for patient safety: Easing the burdens of FDA and industry, The Editors (MDDI, Aug 2001, p. 14).
• (Washington Wrap-Up) FDA performance review reveals problems, James Dickinson (MDDI, Aug 2001, p. 40). Keywords: Regulatory Affairs.
• FDA's Regulation of Internet Promotion and Advertising, Jeffrey Shapiro (MDDI, Jul 2001, p. 84). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) FDA Reverses Stance on Firm's News Release, James Dickinson (MDDI, Jul 2001, p. 40).
• (First Person) Listening to industry, Les Weinstein (MDDI, May 2001, p. 48).
• (Washington Wrap-Up) Shifting the device risk burden, James Dickinson (MDDI, May 2001, p. 56).
• Medical Device Software Standards: Vision and Status, Sherman Eagles (MDDI, May 2001, p. 102). Keyword: Standards.
• (Washington Wrap-Up) An FDA veteran's toughest device approval, James Dickinson (MDDI, Apr 2001, p. 38).
• (Washington Wrap-Up) FDA and the temptations of expanded authority, James Dickinson (MDDI, Mar 2001, p. 40).
• Establishment Registration Update, Robert Drummond (MDDI, Mar 2001, p. 140).
• Preparing for an FDA Advisory Committee Meeting, Karen Harder (MDDI, Mar 2001, p. 127).
• (Editor's Page) An Unceremonious Exit: Does Henney Leave a Newly Politcized FDA?, Jon Katz (MDDI, Feb 2001, p. 14). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) When FDA Doesn't Want Preemption, James Dickinson (MDDI, Feb 2001, p. 42). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) FDA Guidance of Review Procedures Made Available, James Dickinson (MDDI, Jan 2001, p. 50). Keyword: Guidances.
• (Editor's Page) Agenda for the Century: Henney Pledges Good Science, Openness at FDA, Jon Katz (MDDI, Jan 2001, p. 14). Keyword: Henney.

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2000

• (Washington Wrap-Up) Your device promo on FDA's Web site?, James G. Dickinson (MDDI, Dec 2000, p. 28). Keyword: Industry.
• (Editor's Page) HCFA Under Fire: Frustrations Focus on Reimbursement, Jon Katz (MDDI, Dec 2000, p. 14). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) An Echo of FDA Wrongdoing?, James G. Dickinson (MDDI, Nov 2000, p. 36). Keywords: Premarket Approval.
• (Washington Wrap-Up) New FDA review chief brings industry background, James G. Dickenson (MDDI, Oct 2000, p. 40).
• (Washington Wrap-Up) Justify Device Reuse Curbs on Your Labels, FDA Says, James G. Dickinson (MDDI, Aug 2000, p. 34). Keyword: Reuse.
• (Washington Wrap-Up) FDA's Plan for Web-Based Device Labeling, James Dickinson (MDDI, Jul 2000, p. 24). Keyword: Industry.
• (Washington Wrap-Up) FDA Proposes Easier Device Tracking Rule, James Dickinson (MDDI, Jun 2000, p. 40). Keyword: Tracking.
• (Washington Wrap-Up) HIMA, FDA Converge on Third-Party Reviews, James Dickinson (MDDI, May 2000, p. 58). Keyword: Reviews.
• (Washington Wrap-Up) Finally, FDA Moves Broadly on Device Reprocessors, James Dickinson (MDDI, Apr 2000, p. 32). Keyword: Reprocessing.
• (Verbatim) Shaping Initiatives that Lead to Stronger Healthcare, Pamela Bailey (MDDI, Mar 2000, p. 90). Keyword: Regulatory.
• (Washington Wrap-Up) FDA to Industry: Keep Your Own Secrets, James Dickinson (MDDI, Mar 2000, p. 40). Keyword: Industry.
• (Washington Wrap-Up) On Reprocessors and Research, FDA Gently Yields, James Dickinson (MDDI, Feb 2000, p. 32). Keyword: Reprocessing.
• (Clinical Trials) Complying with FDA's Financial Disclosure Regulation, Barry Sall (MDDI, Jan 2000, p. 176). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) FDA Going "Direct" to Device Companies, James Dickinson (MDDI, Jan 2000, p. 40). Keyword: Trends.

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1999

• (Washington Wrap-Up) Are You a Surrogate for an FDA Inspector?, James Dickinson (MDDI, Dec 1999, p. 26). Keyword: Inspections.
• (Washington Wrap-Up) A Scholarly Article You Can't Promote, James Dickinson (MDDI, Nov 1999, p. 32). Keyword: Compliance.
• (Washington Wrap-Up) Novel Devices Won't Suffer, but the Others?, James Dickinson (MDDI, Oct 1999, p. 50). Keyword: Modernization.
• (Washington Wrap-Up) New FDA Devices Chief Feigal: A Positive First Impression, James Dickinson (MDDI, Sep 1999, p. 36). Keyword: CDRH.
• (Washington Wrap-Up) Third-Party Device Review Beat FDA's, James Dickinson (MDDI, Aug 1999, p. 34). Keywords: Third-party review.
• (Washington Wrap-Up) FDA Action Plan to Improve Regulation of Biologic Devices, James Dickinson (MDDI, Jul 1999, p. 32). Keyword: Regulatory.
• (Washington Wrap-Up) Device User Fees: More Needed than Ever Just as Unpopular, James Dickinson (MDDI, Jun 1999, p. 56). Keywords: User fees.
• From FDA Quality System Regulation to CE Marking, Ron Belmont (MDDI, May 1999, p. 150). Keyword: Regulations.
• Understanding FDA's Electronic Records and Signatures Regulation, Jeffrey Gibbs (MDDI, May 1999, p. 134). Keyword: Regulations.
• (Washington Wrap-Up) File Closes on Document Leak, James Dickinson (MDDI, May 1999, p. 70). Keyword: Industry.
• (First Person) FDA/Industry Partnerships: Moving toward More Equitable Enforcement, Nancy Singer (MDDI, May 1999, p. 58). Keyword: Regulations.
• Casting an Interactive Web: Henney Seeks Real-Time Input from Industry, Jon Katz (MDDI, May 1999, p. 12). Keyword: Henney.
• (Washington Wrap-Up) Careful Study Marks Henney's First Month, James Dickinson (MDDI, Apr 1999, p. 32). Keywords: Regulatory Affairs.
• (Washington Wrap-Up) Lightening the Regulatory Burden, James Dickinson (MDDI, Mar 1999, p. 46). Keyword: Regulations.
• (Washington Wrap-Up) FDA Finalizes Off-Label Dissemination Rule, James Dickinson (MDDI, Feb 1999, p. 26). Keyword: Labeling.
• (Combination Devices) Device and Biologic Combination Products: Understanding the Evolving Regulation, Sharon Segal (MDDI, Jan 1999, p. 180). Keywords: Device Evaluation.
• (Section 207) Section 207: Is Your Class III Designation Really Final?, H. Neal Dunning (MDDI, Jan 1999, p. 117). Keywords: Device Evaluation.
• (Washington Wrap-Up) Year-End Report Notes Faster Reviews, More Changes at FDA, James Dickinson (MDDI, Jan 1999, p. 52). Keywords: FDA Report.
• (First Person) FDAMA: One Year Later: An Anniversary Review of the Legislation, James Benson (MDDI, Jan 1999, p. 40). Keywords: FDA Reform.
• The Voice from the Top: Henney's "Recall" Signals A New Era at FDA, Jon Katz (MDDI, Jan 1999, p. 12). Keywords: FDA Reform.

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1998

• "(Washington Wrap-Up) FDA Promotes Shorter PMA Summaries, Faster Inspections", James G. Dickinson (MDDI, Dec 1998, p. 24). Keywords: FDA Reform.
• (Washington Wrap-Up) Henney Shows Friendly Face to Device Makers, James Dickinson (MDDI, Nov 1998, p. 30). Keywords: FDA leadership.
• How Will Medical Devices Fare in Henney's FDA?, James Dickinson (MDDI, Sep 1998, p. 42). Keyword: Henney.
• Making Her World Work: The Nominee for FDA Commission, Jane Henney (MDDI, Sep 1998, p. 30). Keyword: Henney.
• FDA Emphasizes CEO Acoountability, James G. Dickinson (MDDI, Aug 1998, p. 30). Keyword: Regulatory.
• FDA's New Financial Disclosure Rule: An Unnecessary New Burden, Jeffrey N. Gibbs (MDDI, Aug 1998, p. 26). Keyword: Financial.
• The Year 2000: FDA's Absolute Last Word (for the moment... ), Jon Katz (MDDI, Aug 1998, p. 10). Keywords: Year 2000.
• (Washington Wrap-Up) Does FDA Need Its Strong-Arm Enforcers?, James Dickinson (MDDI, Jul 1998, p. 28). Keyword: Regulatory.
• (FDA Modernization Act) Implementation of the FDA Modernization Act of 1997, Jonathan Kahan (MDDI, Jun 1998, p. 81).
• (Washington Wrap-Up) Industry Seeks to Stop FDA Budget Cuts, James Dickinson (MDDI, Jun 1998, p. 36).
• (FDA Modernization Act) The FDA Modernization Act of 1997: Part II, Jonathan Kahan (MDDI, Apr 1998, p. 77).
• (Washington Wrap-Up) FDA Faces the Budget Ax, James G. Dickinson (MDDI, Apr 1998, p. 35).
• FDA's Newest Guidance Document: When the Label Doesn't Fit, Stacey Bell (MDDI, Apr 1998, p. 12).
• The FDA Modernization Act of 1997: Part 1, Jonathan S. Kahan (MDDI, Mar 1998, p. 105).
• 1998 Business Outlook: Prospects for Growth, Stacey L. Bell (MDDI, Mar 1998, p. 85).
• (Washington Wrap-Up) Tighter FDA Budget May Mean Fewer, Shorter Inspections, James G. Dickinson (MDDI, Mar 1998, p. 44).
• (First Person) FDA Reforms Are Rolling, so It's Time to Focus on Going Global, John W. Galiardo (MDDI, Mar 1998, p. 36).
• Will 1998 Be the Year of Reimbursement?, Stacey Bell (MDDI, Mar 1998, p. 12).
• (Washington Wrap-Up) Device Industry Wins Big in FDA Reform, James G. Dickinson (MDDI, Feb 1998, p. 46).
• (First Person) Lessons Learned, New Challenges: Life after FDA Reform, Jeffrey J. Kimbell (MDDI, Feb 1998, p. 34).
• (Washington Wrap-Up) A Troubled Affair, James G. Dickinson (MDDI, Jan 1998, p. 60). Keywords: FDA-Industry Relations.
• (News) FDA Modernization Act Becomes Law (MDDI, Jan 1998, p. 19). Keywords: FDA Reform.
• (News) FDA Hopes to Pilot Third-Party On-Site Inspections (MDDI, Jan 1998, p. 19). Keyword: Inspections.
• The FDA Modernization Act: Staying a New Course, Stacey Bell (MDDI, Jan 1998, p. 12). Keywords: FDA Reform.

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1997

• (Washington Wrap-Up) Rare Harmony Marks FDA Reform Bills on Hill, James G. Dickinson (MDDI, Dec 1997, p. 32). Keywords: FDA Reform.
• The New FDA Regulation on Reports of Corrections and Removals, Jonathan S. Kahan (MDDI, Sep 1997, p. 96). Keywords: Product Recalls.
• (News) Third-Party Pilot Floundering (MDDI, Aug 1997, p. 26). Keywords: Product Submissions.
• (Washington Wrap-Up) FDA Invites Industry to Accept a Faster Alternative to PMAs, James G. Dickinson (MDDI, Jul 1997, p. 36). Keywords: Product Review.
• (News) Lawsuit May Force FDA to Redefine Drugs and Devices (MDDI, Jul 1997, p. 17). Keywords: Combination Products.
• (Washington Wrap-Up) In Its Bold New Course, FDA Needs Industry's Help, James G. Dickinson (MDDI, Jun 1997, p. 52). Keywords: FDA Reform.
• (Letters) FDA Guidance on 510(k) Submissions, Lonnie Witham (MDDI, Jun 1997, p. 32). Keywords: Product Submissions.
• The Progress and Potential of FDA Inspections, Nancy Singer (MDDI, May 1997, p. 74). Keyword: Inspections.
• (Letters) Improving Device Evaluation, Louis Hlavinka (MDDI, May 1997, p. 58). Keywords: FDA Reform.
• (News) Burlington: CDRH to Reengineer (MDDI, May 1997, p. 20). Keywords: FDA Reform.
• (Washington Wrap-Up) A "New Way of Life" at FDA, James G. Dickinson (MDDI, Mar 1997, p. 50). Keywords: FDA Reform.
• (Washington Wrap-Up) After Kessler, What Kind of FDA?, James G. Dickinson (MDDI, Feb 1997, p. 42). Keywords: FDA Reform.
• Three Cheers for Free Thinking at FDA, John Bethune (MDDI, Feb 1997, p. 12). Keywords: FDA Reform.
• (Washington Wrap-Up) Another Bloody Season in the FDA-Congress Wars?, James G. Dickinson (MDDI, Jan 1997, p. 68). Keywords: FDA Reform.
• (News) Design Control Inspections: FDA Seeks Comments (MDDI, Jan 1997, p. 21). Keyword: Inspections.

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1996

• (Washington Wrap-Up) FDA Reform Legislation Does a Slow Fade, James G. Dickinson (MDDI, Nov 1996, p. 42). Keywords: FDA Reform.
• (Washington Wrap-Up) New-Age FDA Brings Many Reforms, James G. Dickinson (MDDI, Sep 1996, p. 54). Keywords: FDA Reform.
• Leadership and Reform: FDA's Ongoing Duty, Robert L. Sheridan (MDDI, Aug 1996, p. 24). Keyword: Organization.
• (Guest Editorial) FDA and the Cost of Health Care, Ronald C. Allen (MDDI, Jul 1996, p. 28). Keywords: Cost Containment.
• (Guest Editorial) Legislating a New and Improved FDA, James C. Greenwood (MDDI, Jun 1996, p. 26). Keywords: FDA Reform.
• (Washington Wrap-Up) Heroic Efforts to Save FDA Reform, James G. Dickinson (MDDI, May 1996, p. 54). Keywords: FDA Reform.
• (News) Partnership Efforts Take Roots-Up Approach (MDDI, May 1996, p. 16). Keywords: Industry Relations.
• Warning Letter: Regulation Only Works as a Partnership, John Bethune (MDDI, May 1996, p. 10). Keywords: Industry Relations.
• (Washington Wrap-Up) Reporting Rule Serves as a Test of Agency Reform, James G. Dickinson (MDDI, Apr 1996, p. 24). Keywords: Medical Device Reporting.
• Burlington to HIMA: A Challenge, or a Threat?, John Bethune (MDDI, Apr 1996, p. 8). Keywords: Industry Relations.
• FDA's Small Business Representatives: Lending a Helping Hand to Small Device Firms, Mark Roh (MDDI, Feb 1996, p. 52). Keywords: Small Business.
• (Washington Wrap-Up) FDA and Industry Must Agree, James G. Dickinson (MDDI, Feb 1996, p. 46). Keywords: Industry Relations.
• (Washington Wrap-Up) Breakthrough at FDA, James G. Dickinson (MDDI, Jan 1996, p. 60). Keywords: Industry Relations.

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1995

• (Washington Wrap-Up) Former Bard Executives Found Guilty, James G. Dickinson (MDDI, Dec 1995, p. 40). Keywords: Criminal Prosecution.
• (Washington Wrap-Up) The System Works, James G. Dickinson (MDDI, Dec 1995, p. 34). Keywords: FDA Reform.
• The Time for Change is Now, William W. George (MDDI, Dec 1995, p. 22). Keywords: FDA Reform.
• (Washington Wrap-Up) FDA Criminal Investigation, James G. Dickinson (MDDI, Nov 1995, p. 45). Keywords: Criminal Prosecution.
• (Washington Wrap-Up) FDA Still Winning, James G. Dickinson (MDDI, Nov 1995, p. 42). Keywords: FDA Reform.
• FDA Could Benefit from Europe's Device Review Model, Robert G. Britain (MDDI, Nov 1995, p. 24). Keywords: FDA Reform.
• (Washington Wrap-Up) An FDA 'Coincidence' at COBE, James G. Dickinson (MDDI, Oct 1995, p. 52). Keyword: Enforcement.
• (Washington Wrap-Up) FDA Critics Moderate Reform Calls, James G. Dickinson (MDDI, Oct 1995, p. 48). Keywords: FDA Reform.
• (Washington Wrap-Up) Laerdal: FDA Eats a Little Crow, James G. Dickinson (MDDI, Oct 1995, p. 48). Keyword: Enforcement.
• FDA's New Approach to Conducting Device GMP Inspections, Z. Frank Twardochleb (MDDI, Sep 1995, p. 58). Keyword: Enforcement.
• FDA Needs to Make Inspections More Predictable, David M. Link (MDDI, Sep 1995, p. 36). Keywords: FDA Reform.
• (Washington Wrap-Up) New Numbers, James G. Dickinson (MDDI, Aug 1995, p. 49). Keyword: Personnel.
• (Washington Wrap-Up) Marketing 'Fire Wall' Law Sought, James G. Dickinson (MDDI, Aug 1995, p. 49). Keyword: Labeling.
• (Washington Wrap-Up) FDA Marketing Role Attacked, James G. Dickinson (MDDI, Aug 1995, p. 48). Keyword: Labeling.
• (Washington Wrap-Up) 510(k) Backlog Reduced by 50%, James G. Dickinson (MDDI, Aug 1995, p. 48). Keywords: Review Process.
• (Washington Wrap-Up) Anger Won't Reform FDA, James G. Dickinson (MDDI, Aug 1995, p. 46). Keywords: FDA Reform.
• FDA Needs to Shed Guns-and-Badges Image, Brian Donato (MDDI, Aug 1995, p. 24). Keywords: FDA Reform.
• Obvious Benefits Make Reform Likely, George M. Burditt (MDDI, Aug 1995, p. 24). Keywords: FDA Reform.
• (Washington Wrap-Up) FDA Clears Siemens, James G. Dickinson (MDDI, Jul 1995, p. 40). Keyword: Enforcement.
• (Washington Wrap-Up) A Sea Change at FDA, James G. Dickinson (MDDI, Jul 1995, p. 38). Keywords: FDA Reform.
• The Information Disequilibrium: One Argument in Favor of FDA, John Bethune (MDDI, Jul 1995, p. 8). Keywords: FDA Reform.
• (Washington Wrap-Up) FDA Outflanks Its Hill Critics, James G. Dickinson (MDDI, Jun 1995, p. 32). Keywords: FDA Reform.
• (News) HIMA Disputes Kessler Review-Time Testimony (MDDI, Jun 1995, p. 14). Keywords: Review Process.
• (News) CDRH Tests Personal Touch (MDDI, Jun 1995, p. 10). Keyword: CDRH.
• (Washington Wrap-Up) How Slow Can FDA Go?, James G. Dickinson (MDDI, May 1995, p. 66). Keyword: Classification.
• (Washington Wrap-Up) When FDA Seems to Play Favorites, James G. Dickinson (MDDI, May 1995, p. 62). Keywords: Review Process.
• (Interview) Climbing the Hill for FDA Reform, Susan Zagame (MDDI, May 1995, p. 52). Keywords: FDA Reform.
• Speeding Regulatory Reform, Max Sherman (MDDI, May 1995, p. 42). Keywords: FDA Reform.
• CDRH Can Learn--But Hasn't Graduated, H. Neal Dunning (MDDI, May 1995, p. 42). Keywords: FDA Reform.
• (Washington Wrap-Up) Burlington Seeks Goal-Oriented Reform, James G. Dickinson (MDDI, Apr 1995, p. 28). Keywords: FDA Reform.
• (Washington Wrap-Up) Hatch Sees Big FDA Changes, James G. Dickinson (MDDI, Apr 1995, p. 26). Keywords: FDA Reform.
• (Guest Editorial) FDA's Reference List: A Starting Place for Reform, James R. Phelps (MDDI, Apr 1995, p. 20). Keyword: Enforcement.
• (Washington Wrap-Up) Why FDA Cites Corrected Problems, James G. Dickinson (MDDI, Mar 1995, p. 44). Keyword: Enforcement.
• (Washington Wrap-Up) 'Reference List' May Be Changed, James G. Dickinson (MDDI, Mar 1995, p. 40). Keyword: Enforcement.
• (Washington Wrap-Up) FDA Reform is Top Goal, James G. Dickinson (MDDI, Mar 1995, p. 40). Keywords: FDA Reform.
• (Washington Wrap-Up) Anti-Kessler Drive Accelerates, James G. Dickinson (MDDI, Feb 1995, p. 44). Keyword: Personnel.
• (Washington Wrap-Up) Slow Revolution in Washington, James G. Dickinson (MDDI, Feb 1995, p. 44). Keywords: FDA Reform.
• Can FDA Keep Up with Technology?, John Bethune (MDDI, Feb 1995, p. 8). Keywords: FDA Reform.
• (Washington Wrap-Up) FDA Investigators Face 'Culture Change', James G. Dickinson (MDDI, Jan 1995, p. 70). Keyword: Organization.
• (Washington Wrap-Up) Device Reference List 'Is Illegal', James G. Dickinson (MDDI, Jan 1995, p. 68). Keyword: Enforcement.
• (Washington Wrap-Up) Laerdal Case Teaches Sobering Lessons, James G. Dickinson (MDDI, Jan 1995, p. 66). Keyword: Enforcement.
• (News) EPT Device Approval Shows Model for Timely PMA Reviews (MDDI, Jan 1995, p. 34). Keywords: Product Approval.
• When the New Congress Talks, Will FDA Listen?, John Bethune (MDDI, Jan 1995, p. 10). Keywords: FDA Reform.

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1994

• (Washington Wrap-Up) In Vitro Devices Office Rejected, James G. Dickinson (MDDI, Dec 1994, p. 31). Keyword: Organization.
• (Washington Wrap-Up) More Data Sought on Breast Pads, James G. Dickinson (MDDI, Dec 1994, p. 30). Keywords: Product Approval.
• (Washington Wrap-Up) Will 'Early Out' Offer Hurt FDA?, James G. Dickinson (MDDI, Nov 1994, p. 30). Keyword: Personnel.
• (Washington Wrap-Up) FDA to Certify Its Investigators, James G. Dickinson (MDDI, Nov 1994, p. 30). Keyword: Personnel.
• (Washington Wrap-Up) Should FDA Bashers Blame Congress Instead?, James G. Dickinson (MDDI, Nov 1994, p. 26). Keywords: Product Approval.
• (Washington Wrap-Up) FDA Partnerships with State and Local Agencies Unveiled, James G. Dickinson (MDDI, Oct 1994, p. 70). Keyword: Organization.
• (Washington Wrap-Up) Faster PMA Processing, James G. Dickinson (MDDI, Oct 1994, p. 64). Keywords: Review Process.
• (Washington Wrap-Up) More Inspections, Fewer FDA Warnings, James G. Dickinson (MDDI, Sep 1994, p. 36). Keyword: Enforcement.
• (News) FDA Scrambles to Reconstitute GMP Advisory Committee (MDDI, Sep 1994, p. 10). Keyword: Organization.
• FDA in Cyberspace, John Bethune (MDDI, Sep 1994, p. 8). Keywords: On-Line Access.
• (Washington Wrap-Up) 'Phased' Device Approvals, James G. Dickinson (MDDI, Jul 1994, p. 33). Keywords: Review Process.
• (Washington Wrap-Up) Bard Recall 'Not Related to Warning Letter', James G. Dickinson (MDDI, Jul 1994, p. 32). Keyword: Enforcement.
• (Washington Wrap-Up) Reply to Pilot, James G. Dickinson (MDDI, Jul 1994, p. 30). Keywords: Review Process.
• (Washington Wrap-Up) FDA Reviewers Wasting Time?, James G. Dickinson (MDDI, Jun 1994, p. 44). Keywords: Review Process.
• (Washington Wrap-Up) FDA Field Decentralization, James G. Dickinson (MDDI, May 1994, p. 70). Keyword: Organization.
• (Washington Wrap-Up) How FDA Thinks about Industry, James G. Dickinson (MDDI, Apr 1994, p. 26). Keyword: Performance.
• (Washington Wrap-Up) FDA Functions Streamlined via ORA 21 and ISO 9001, James G. Dickinson (MDDI, Mar 1994, p. 42). Keyword: Organization.
• (Interview) Confronting the ODE Backlog, Susan Alpert (MDDI, Mar 1994, p. 32). Keywords: Review Process.
• (News) ODE Issues Guidance on Reviewer Disputes (MDDI, Mar 1994, p. 20). Keywords: Review Process.
• (Washington Wrap-Up) HIMA Calls for Dramatic Improvement in FDA Review Times, James G. Dickinson (MDDI, Feb 1994, p. 32). Keywords: Review Process.
• Dangerous Powers: Civil Penalties and FDA, Jonathan S. Kahan (MDDI, Jan 1994, p. 98). Keyword: Enforcement.
• (Interview) New FDA Office Consolidates Postmarket Surveillance Effort, Janet Arrowsmith-Lowe (MDDI, Jan 1994, p. 42). Keyword: Organization.
• FDA and the Art of Definition, John Bethune (MDDI, Jan 1994, p. 10). Keyword: Labeling.

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1993

• Will New Policies Make a Faster Track for Product Reviews?, William D. Appler (MDDI, Nov 1993, p. 44). Keyword: Policy.
• Guest Editorial: Why Sharps Safety Regulations Won't Work, Gary Cohen (MDDI, Nov 1993, p. 30). Keyword: Policy.
• News: Device Center Launches Quarterly Teleconference (MDDI, Nov 1993, p. 12). Keyword: CDRH.
• FDA's New Guide to Writing Manuals for Home-Care Devices, Cathy Backinger (MDDI, Oct 1993, p. 82). Keywords: Home-Care Devices, Assistance.
• News: Device Center Study Cites Common GMP Problems (MDDI, Oct 1993, p. 10). Keywords: CDRH, GMPs.
• Washington Wrap-Up: Reluctant OK for User Fees (A); Committee Report Supports Burlington; Recommendations for Reform; 510(k) Status Reporting System; FDA Moves against Sterilants; Changes at CDRH, James G. Dickinson (MDDI, Sep 1993, p. 38). Keywords: CDRH, FDAEnforcement, 510(k), User Fees, Government Criticism, Personnel.
• Guest Editorial: Keeping Devices Off the Market Does Not Protect the Consumer, William D. Appler (MDDI, Aug 1993, p. 24). Keyword: Policy.
• News: Device Center Schedules Workshop (MDDI, Aug 1993, p. 10). Keyword: CDRH.
• Face to Face: Compliance and Enforcement--Past, Present, and Future: An Interview with William H. Damaska, Regulatory Affairs Consultant, C. L. McIntosh & Associates, Rockville, MD, William H. Damaska (MDDI, Jul 1993, p. 32). Keyword: Compliance.
• Guest Editorial: Can CDRH Learn from the Lessons of Its Past?, H. Neal Dunning (MDDI, Jul 1993, p. 26). Keyword: CDRH.
• News: Device Center Brain Drain Accelerates (MDDI, Jul 1993, p. 16). Keyword: CDRH.
• Guest Editorial: Trust and Leadership, Larry R. Pilot (MDDI, May 1993, p. 34). Keywords: CDRH, Management.
• News: New Phone Policy One More Way FDA Attempts to Communicate (MDDI, May 1993, p. 28). Keyword: Policy.
• News: CDRH and HIMA at Odds over Temple Report Findings (MDDI, May 1993, p. 20). Keywords: CDRH, Clinical Investigations.
• When HIMA Met Kessler, John Bethune (MDDI, May 1993, p. 10). Keyword: Kessler.
• Washington Wrap-Up: Kessler Retained; FDA to the Rescue; FDA Can Be Dangerous, Too; Temple Committee Findings; Erroneous Report on Breast Implants; FDA Unbound; Straight Talk from FDA, James G. Dickinson (MDDI, Apr 1993, p. 44). Keywords: Guidelines, FDAEnforcement, Government Criticism, Criticism Task Forces, Product Liability, Industry Opinion, Personnel, HIMA.
• New Standards for Clinical Studies, John Bethune (MDDI, Apr 1993, p. 8). Keywords: Criticism Task Forces, Clinical Investigations.
• News: Kessler Names New Device Center Director (MDDI, Mar 1993, p. 10). Keywords: CDRH, Personnel.
• Guest Editorial: What Is FDA's Mission?, James R. Phelps (MDDI, Feb 1993, p. 20). Keyword: Policy.

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1992

• Washington Wrap-Up: Fixing What's Broke at FDA; CDRH Reorganization; User-Fee Legislation; Improving Submissions, James G. Dickinson (MDDI, Nov 1992, p. 32). Keywords: Policy, Product Approvals, CDRH, User Fees.
• News: Can Communication Overcome FDA Politics?, MD&DI (MDDI, Nov 1992, p. 10). Keywords: Policy, FDAEnforcement.
• News: No Money for Data Base, Benson Says, MD&DI (MDDI, Nov 1992, p. 10). Keywords: Biomaterials, Assistance.
• Dingell's Wrath: Will It Help?, John Bethune (MDDI, Oct 1992, p. 8). Keywords: CDRH, Kessler.
• News: Commissioner Kessler's 'Communication Thing', MD&DI (MDDI, Sep 1992, p. 10). Keywords: ODE, CDRH, Kessler.
• Washington Wrap-Up: Curbing device marketers; CDRH tension eases; FDA wants more power, James G. Dickinson (MDDI, Aug 1992, p. 28). Keywords: CDRH, FDA Policy.
• News: FDA announces latex conference, MD&DI (MDDI, Aug 1992, p. 10). Keyword: Assistance.
• Take A Message, John Bethune (MDDI, Aug 1992, p. 8). Keyword: Policy.
• Washington Wrap-Up: Naming names at FDA; Device-science task force; Common sense, Anyone?, James G. Dickinson (MDDI, Jul 1992, p. 36). Keywords: Criticism Task Forces, Labeling, Personnel.
• Washington Wrap-up: Revolution at FDA; Device tracking, James G. Dickinson (MDDI, Jun 1992, p. 42). Keywords: Congressional Hearings, CDRH, Device Tracking, Management.
• Washington Wrap-up: When compliance is voluntary; Preapproval inspections for 510(k)s; User reporting rule; International Harmonization, James G. Dickinson (MDDI, Mar 1992, p. 40). Keywords: User Reporting, FDAEnforcement, Harmonization, Compliance, 510(k)s, Management, Inspections.
• Face to face with FDA: an interview with James S. Benson, Director, CDRH, Cliff Henke (MDDI, Mar 1992, p. 30). Keywords: Management, Regulatory Climate.
• Face to face with FDA: an interview with David West, Deputy Director, Office of Device Evaluation, CDRH, Cliff Henke (MDDI, Feb 1992, p. 18). Keywords: ODE, Regulatory Climate, Product Approval.

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1991

• Washington Wrap-up: More attorneys to help FDA, James G. Dickinson (MDDI, Nov 1991, p. 84). Keyword: Personnel.
• FDA: moving aggressively toward the future, Louis W. Sullivan (MDDI, Nov 1991, p. 12). Keywords: FDAEnforcement, Management, Product Approval.
• Biological in vitro diagnostics, Amiram Daniel (MDDI, Oct 1991, p. 34). Keywords: Diagnostics, Blood Devices, CBER.
• Washington Wrap-up: FDA getting through, James G. Dickinson (MDDI, Oct 1991, p. 28). Keywords: Management, Product Approval, Government-Industry Cooperation.
• Washington Wrap-up: New CDRH command, James G. Dickinson (MDDI, Sep 1991, p. 97). Keywords: CDRH, Personnel.
• Washington Wrap-up: FDA integrity counsel, James G. Dickinson (MDDI, Sep 1991, p. 97). Keyword: Personnel.
• Washington Wrap-up: Form of autonomy (A), James G. Dickinson (MDDI, Sep 1991, p. 26). Keyword: Organization.
• Washington Wrap-up: Top lawyer leaves FDA, James G. Dickinson (MDDI, Aug 1991, p. 28). Keyword: Personnel.
• Washington Wrap-up: New FDA policies, James G. Dickinson (MDDI, Aug 1991, p. 24). Keywords: Policy, CDRH, Product Approval.
• Washington Wrap-up: FDA leadership changes, James G. Dickinson (MDDI, Jul 1991, p. 23). Keywords: Management, Organization.
• Washington Wrap-up: Unleashing the investigators, James G. Dickinson (MDDI, Jun 1991, p. 32). Keyword: Management.
• Washington Wrap-up: Kessler gets tough, James G. Dickinson (MDDI, Jun 1991, p. 30). Keywords: FDAEnforcement, Management.
• Washington Wrap-up: Advisory committee ambush, James G. Dickinson (MDDI, May 1991, p. 24). Keywords: Advisory Committees.
• Washington Wrap-up: Reforming FDA internally, James G. Dickinson (MDDI, Apr 1991, p. 24). Keywords: Management, Organization, Personnel.
• Washington Wrap-up: FDA consolidation, James G. Dickinson (MDDI, Apr 1991, p. 20). Keyword: Buildings.
• Washington Wrap-up: FDA treading water, James G. Dickinson (MDDI, Apr 1991, p. 18). Keywords: CDRH, Organization.
• Good guys, bad guys, and device reviews, William D. Appler (MDDI, Mar 1991, p. 32). Keywords: Policy, FDAEnforcement.
• Washington Wrap-up: FDA ombudsman is 'open for business', James G. Dickinson (MDDI, Mar 1991, p. 21). Keyword: Personnel.
• Washington Wrap-up: More enforcement (again), James G. Dickinson (MDDI, Mar 1991, p. 20). Keywords: Kessler, Regulatory Climate.
• Washington Wrap-up: New FDA commissioner, James G. Dickinson (MDDI, Feb 1991, p. 28). Keywords: Kessler, Management.
• Washington Wrap-up: FDA on upswing, James G. Dickinson (MDDI, Jan 1991, p. 32). Keywords: Organization, Management.

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1990

• Washington Wrap-up: New fraud policy, James G. Dickinson (MDDI, Dec 1990, p. 25). Keywords: Policy, FDAEnforcement.
• Washington Wrap-up: Gundaker in charge, James G. Dickinson (MDDI, Nov 1990, p. 28). Keywords: Gundaker, CDRH.
• Washington Wrap-up: No generic-drug scandal, James G. Dickinson (MDDI, Nov 1990, p. 28). Keywords: Policy, Personnel.
• Face to face with FDA: an interview with Robert L. Sheridan, Director, Office of Device Evaluation, CDRH (MDDI, Nov 1990, p. 18). Keywords: Advisory Panels, Product Approval.
• Washington Wrap-up: Villforth's retirement, James G. Dickinson (MDDI, Sep 1990, p. 32). Keywords: Villforth, Personnel.
• Face to face with FDA: an interview with Joseph S. Arcarese, Director, Office of Training and Assistance, CDRH (MDDI, Sep 1990, p. 20). Keywords: Public Health Promotion, End-Users, Assistance.
• Washington Wrap-up: O'Connell honored, James G. Dickinson (MDDI, Aug 1990, p. 35). Keywords: Diagnostics, Personnel.
• Washington Wrap-up: Edwards panel update, James G. Dickinson (MDDI, Aug 1990, p. 32). Keyword: Organization.
• News: Villforth retires from CDRH, Greg Freiherr (MDDI, Aug 1990, p. 26). Keywords: Villforth, Personnel.
• Washington Wrap-up: Rebuilding FDA, James G. Dickinson (MDDI, Jul 1990, p. 30). Keyword: Organization.
• Washington Wrap-up: Ignoring the analysts, James G. Dickinson (MDDI, Jul 1990, p. 28). Keyword: Management.
• Face to face with FDA: an interview with Walter Gundaker, Acting Deputy Director, CDRH (MDDI, Jul 1990, p. 16). Keywords: FDAEnforcement, Legislation, MDR, Assistance.
• FDA Notes: ODE guidance, William D. Appler (MDDI, May 1990, p. 32). Keywords: ODE, Guidelines.
• FDA Notes: ODE annual report, William D. Appler (MDDI, May 1990, p. 30). Keyword: ODE.
• Washington Wrap-up: New rules for FDA employees, James G. Dickinson (MDDI, Apr 1990, p. 28). Keyword: Personnel.
• Washington Wrap-up: Benson wins early praise, James G. Dickinson (MDDI, Apr 1990, p. 24). Keyword: Benson.
• Some free advice for ODE, William D. Appler (MDDI, Mar 1990, p. 36). Keywords: ODE, 510(k)s, Industry Opinion.
• Washington Wrap-up: Sealing CDRH buildings, James G. Dickinson (MDDI, Mar 1990, p. 31). Keywords: Buildings, CDRH.
• Washington Wrap-up: Benson opportunity (The), James G. Dickinson (MDDI, Mar 1990, p. 28). Keywords: Benson, Management.
• Washington Wrap-up: Benson 'rescued', James G. Dickinson (MDDI, Feb 1990, p. 27). Keywords: Political Influence, Management.
• Washington Wrap-up: Huge loss at FDA (A), James G. Dickinson (MDDI, Jan 1990, p. 22). Keywords: Political Influence, Personnel.
• News: Young steps down as FDA commissioner (MDDI, Jan 1990, p. 18). Keyword: Young.

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1989

• Washington Wrap-up: FDA politicization, Larry Oster (MDDI, Dec 1989, p. 31). Keywords: Political Influence, Personnel.
• Washington Wrap-up: Approval with training, Larry Oster (MDDI, Nov 1989, p. 45). Keywords: Ob/Gyn Devices, Advisory Panels, Product Approval.
• Washington Wrap-up: Scarlett's resignation, Larry Oster (MDDI, Nov 1989, p. 44). Keyword: Personnel.
• Will repercussions from generic drugs affect CDRH decision making?, William D. Appler (MDDI, Nov 1989, p. 22). Keywords: CDRH, Product Approval, Personnel.
• Washington Wrap-up: Silver Spring evacuated, Larry Oster (MDDI, Sep 1989, p. 40). Keyword: Buildings.
• Washington Wrap-up: FDA device scandal? (An), Larry Oster (MDDI, Sep 1989, p. 38). Keywords: Government Criticism, Personnel.
• Undermining DSMA, William D. Appler (MDDI, Sep 1989, p. 28). Keywords: DSMA, Assistance.
• Washington Wrap-up: Us against them, part III, Larry Oster (MDDI, Aug 1989, p. 38). Keyword: Personnel.
• Washington Wrap-up: Us against them, part II, Larry Oster (MDDI, Aug 1989, p. 36). Keywords: Advisory Committees, Personnel.
• Washington Wrap-up: Movement at FDA, Larry Oster (MDDI, Jul 1989, p. 26). Keywords: Organization, Personnel.
• FDA: 10 years in retrospect, Larry Oster (MDDI, Jun 1989, p. 95). Keywords: FDAEnforcement, Organization, Assistance.
• Washington Wrap-up: Conflict of interest, Larry Oster (MDDI, Jun 1989, p. 66). Keyword: Personnel.
• Washington Wrap-up: Cost-effective devices, Larry Oster (MDDI, Jun 1989, p. 64). Keywords: Cost Containment, Advisory Panels, Product Approval.
• Washington Wrap-up: Transition blues, Larry Oster (MDDI, Apr 1989, p. 110). Keywords: Political Influence, Personnel.
• Benefits of an FDA/academic/industry partnership (The), William D. Appler (MDDI, Apr 1989, p. 22). Keywords: District Offices, Biotechnology, Government-Industry Cooperation.
• Assisting the FDA-regulated device industry: the ins and outs, William D. Appler (MDDI, Mar 1989, p. 16). Keywords: Compliance, Consultants, Assistance.
• Washington Wrap-up: More efficient FDA (A), Larry Oster (MDDI, Feb 1989, p. 22). Keywords: Organization, Government-Industry Cooperation.

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1988

• Washington Wrap-up: Quitting Silver Spring, Larry Oster (MDDI, Dec 1988, p. 22). Keywords: Buildings, CDRH.
• Washington Wrap-up: Mohan leaves FDA, Larry Oster (MDDI, Dec 1988, p. 20). Keywords: Mohan, Personnel, Product Approval.
• News: DSMA evaluates workshops (MDDI, Dec 1988, p. 14). Keyword: Assistance.
• Washington Wrap-up: Appealing to the panel, Larry Oster (MDDI, Nov 1988, p. 44). Keywords: Advisory Panels.
• Washington Wrap-up: Consolidating FDA, Larry Oster (MDDI, Sep 1988, p. 40). Keywords: Legislation, Organization.
• Washington Wrap-up: Benson as deputy, Larry Oster (MDDI, Aug 1988, p. 28). Keywords: Benson, Personnel.
• Washington Wrap-up: Other CDRH accomplishments, Larry Oster (MDDI, Jul 1988, p. 22). Keywords: Management, Risk Assessment.
• Washington Wrap-up: Enter Action Plan III, Larry Oster (MDDI, Jul 1988, p. 22). Keyword: Management.
• Industry reps: up from second-class citizenship: an interview with Amiram Daniel, PhD, Director of Diagnostic Manufacturing and Biotechnology Programs, HIMA, David Haut (MDDI, Jul 1988, p. 14). Keywords: Advisory Panels, Government-Industry Cooperation.
• Washington Wrap-up: Villforth's elusive dream, Larry Oster (MDDI, Jun 1988, p. 46). Keyword: CDRH.
• Washington Wrap-up: Repercussions on Capitol Hill and beyond, Larry Oster (MDDI, Apr 1988, p. 18). Keywords: Government Criticism, District Offices.
• News: FDA seeks advisory panel nominations (MDDI, Mar 1988, p. 51). Keywords: Advisory Panels.
• Washington Wrap-up: No resting on its laurels for CDRH, Larry Oster (MDDI, Mar 1988, p. 10). Keywords: CDRH, Product Approval.

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1987

• Washington Wrap-up: No more backlogs!, Larry Oster (MDDI, Dec 1987, p. 10). Keywords: CDRH, Product Approval.
• Washington Wrap-up: FDA to close four regional offices, Larry Oster (MDDI, Oct 1987, p. 16). Keyword: Organization.
• Washington Wrap-up: Less advice, more speed?, Larry Oster (MDDI, Oct 1987, p. 14). Keywords: Advisory Panels, Product Approval.
• Washington Wrap-up: FDA expands its congressional liaison efforts, Larry Oster (MDDI, Sep 1987, p. 20). Keyword: Personnel.
• Washington Wrap-up: Ed McDonnell transferred, Larry Oster (MDDI, Aug 1987, p. 18). Keyword: Personnel.
• Washington Wrap-up: FDA chief a presidential appointee?, Larry Oster (MDDI, Aug 1987, p. 16). Keywords: Political Influence, Management.
• CDRH's Jim Benson: Making systematic improvements in the product evaluation process, James S. Benson (MDDI, Jun 1987, p. 76). Keywords: Forecasts, Product Approval, Assistance.
• Critical devices: guilty until proven innocent?, Eldon E. Frisch (MDDI, Jun 1987, p. 52). Keywords: Advisory Committees, Critical Devices.
• Washington Wrap-up: Trying to attract scientists, Larry Oster (MDDI, Jun 1987, p. 24). Keyword: Personnel.
• Washington Wrap-up: Running out of leaders?, Larry Oster (MDDI, Jun 1987, p. 24). Keywords: Management, Personnel.
• Washington Wrap-up: Update on CDRH's home, Larry Oster (MDDI, Jun 1987, p. 22). Keywords: Buildings, CDRH.
• Washington Wrap-up: Big government again, Larry Oster (MDDI, Jun 1987, p. 20). Keywords: CDRH, Personnel.
• Washington Wrap-up: Candid comment, Larry Oster (MDDI, Mar 1987, p. 26). Keyword: Management.
• Washington Wrap-up: Credit where credit is due, Larry Oster (MDDI, Mar 1987, p. 22). Keyword: Management.
• Washington Wrap-up: Unnecessary measures?, Larry Oster (MDDI, Jan 1987, p. 20). Keyword: CDRH.
• Washington Wrap-up: CDRH won't be moving after all, Larry Oster (MDDI, Jan 1987, p. 20). Keywords: Buildings, CDRH.

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1986

• Washington Wrap-up: Another FDA leader leaves, Larry Oster (MDDI, Dec 1986, p. 23). Keyword: Personnel.
• Washington Wrap-up: Commissioner Young: in for the long haul, Larry Oster (MDDI, Dec 1986, p. 23). Keyword: Young.
• Center for Devices and Radiological Health: organization of offices and divisions and referral list (MDDI, Dec 1986, p. 19). Keywords: CDRH, Organization.
• GMPAC: a perspective, Thomas G. Field, Jr. (MDDI, Dec 1986, p. 8). Keywords: Advisory Committees, Critical Devices, GMPs.
• SMA News: GMP advisory committee has three vacancies (MDDI, Oct 1986, p. 39). Keywords: Advisory Committees.
• Washington Wrap-up: CDRH to relocate, Larry Oster (MDDI, Sep 1986, p. 22). Keywords: Buildings, CDRH.
• Washington Wrap-up: For CDRH, some bad news ..., Larry Oster (MDDI, Sep 1986, p. 20). Keywords: CDRH, Budget Cuts, Recalls.
• SMA News: Progress made on CDRH task force recommendations, H. Neal Dunning (MDDI, Jul 1986, p. 24). Keywords: CDRH, Criticism Task Forces.
• Washington Wrap-up: Dealing with low morale, Larry Oster (MDDI, Jul 1986, p. 16). Keywords: CDRH, Personnel.
• Washington Wrap-up: CDRH's resource shortage, Larry Oster (MDDI, Jul 1986, p. 14). Keywords: CDRH, Industry Opinion.
• Washington Wrap-up: Young to stay at FDA, Larry Oster (MDDI, May 1986, p. 14). Keyword: Young.
• Washington Wrap-up: CDRH in trouble, Larry Oster (MDDI, May 1986, p. 12). Keywords: CDRH, Budget Cuts.
• SMA News: DSMA workshop manuals available (MDDI, Apr 1986, p. 92). Keywords: Manuals, DSMA.
• Washington Wrap-up: Expanded role for advisory committees?, Larry Oster (MDDI, Mar 1986, p. 16). Keywords: Advisory Committees.
• SMA News: More FDA outreach efforts, H. Neal Dunning (MDDI, Jan 1986, p. 28). Keyword: Assistance.
• Washington Wrap-up: AMA support, Larry Oster (MDDI, Jan 1986, p. 20). Keywords: CDRH, Management.
• Washington Wrap-up: CDRH leads the way, Larry Oster (MDDI, Jan 1986, p. 14). Keywords: CDRH, Management.

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1985

• SMA News: New assistance effort initiated, H. Neal Dunning (MDDI, Oct 1985, p. 31). Keywords: Small Manufacturers, DSMA, Assistance.
• SMA News: PMA conditions of approval revised (MDDI, Oct 1985, p. 31). Keywords: Premarket Approvals, Criticism Task Forces.
• Washington Wrap-up: FDA's action plan, Larry Oster (MDDI, Oct 1985, p. 14). Keyword: Policy.
• Washington Wrap-up: FDA in ferment, Larry Oster (MDDI, Sep 1985, p. 12). Keyword: Personnel.
• Washington Wrap-up: FDA internationalism, Larry Oster (MDDI, Jul 1985, p. 16). Keywords: International Affairs, Assistance.
• Washington Wrap-up: FDA committee vacancies, Larry Oster (MDDI, May 1985, p. 110). Keywords: Advisory Committees.
• Washington Wrap-up: Politicization at FDA, Larry Oster (MDDI, May 1985, p. 14). Keywords: Political Influence, Personnel.
• Washington Wrap-up: Recent upheavals at FDA, Larry Oster (MDDI, Apr 1985, p. 18). Keyword: Personnel.
• Washington Wrap-up: Interview with Frank Young (An), Larry Oster (MDDI, Mar 1985, p. 24). Keywords: Young, Management.
• Washington Wrap-up: Toward the 21st century, Larry Oster (MDDI, Feb 1985, p. 18). Keywords: Personnel, Product Approval.
• Washington Wrap-up: Kudos for the commissioner, Larry Oster (MDDI, Jan 1985, p. 14). Keywords: CDRH, Young, Government-Industry Cooperation.

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1984

• Washington Wrap-up: FDA can keep paying its advisors, Larry Oster (MDDI, Oct 1984, p. 16). Keywords: Advisory Committees.
• Washington Wrap-up: FDA advisory constraints, Larry Oster (MDDI, Sep 1984, p. 15). Keywords: Advisory Panels.
• Washington Wrap-up: Advisory deficiencies, Larry Oster (MDDI, Aug 1984, p. 20). Keywords: Advisory Panels.
• Washington Wrap-up: Appointment incites curiosity, Larry Oster (MDDI, Aug 1984, p. 18). Keyword: Young.
• Washington Wrap-up: Wanted: FDA science commissioner, Larry Oster (MDDI, Jun 1984, p. 99). Keyword: Organization.
• Washington Wrap-up: What's in a name?, Larry Oster (MDDI, Jun 1984, p. 98). Keywords: CDRH, Organization.
• Washington Wrap-up: Device law revision, Larry Oster (MDDI, Mar 1984, p. 14). Keywords: Novitch, Amendments.
• Washington Wrap-up: Who will be commissioner?, Larry Oster (MDDI, Jan 1984, p. 60). Keyword: Management.

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1983

• Washington Wrap-up: NCDRH restructuring, Larry Oster (MDDI, Dec 1983, p. 14). Keywords: CDRH, Organization.
• We are from NCDRH and we are still here to help you!, H. Neal Dunning (MDDI, Dec 1983, p. 10). Keywords: Small Manufacturers, DSMA, Assistance.
• FDA's Small Business Assistance Program, Timothy R. Wells (MDDI, Oct 1983, p. 25). Keywords: Small Business, Assistance.
• Washington Wrap-up: Hayes will be missed, Larry Oster (MDDI, Oct 1983, p. 14). Keyword: Hayes.
• Washington Wrap-up: Will Hayes resign?, Larry Oster (MDDI, Sep 1983, p. 16). Keyword: Hayes.
• Washington Wrap-up: Reaching out to HRG, Larry Oster (MDDI, Sep 1983, p. 15). Keywords: HRG, Organization.
• Washington Wrap-up: NCDRH may be consolidated, Larry Oster (MDDI, Sep 1983, p. 14). Keyword: CDRH.
• Washington Wrap-up: BMD's morale still low, Larry Oster (MDDI, Feb 1983, p. 14). Keywords: BMD, Personnel.
• Washington Wrap-up: Changes under Villforth, Larry Oster (MDDI, Jan 1983, p. 16). Keywords: CDRH, Villforth, Organization.

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1982

• Washington Wrap-up: Hayes badly prepared, Larry Oster (MDDI, Oct 1982, p. 14). Keywords: Congressional Hearings, Hayes, Government Criticism.
• Washington Wrap-up: Hayes resignation rumors, Larry Oster (MDDI, Sep 1982, p. 16). Keyword: Hayes.
• Washington Wrap-up: Villforth in, Zafra out, Larry Oster (MDDI, Sep 1982, p. 16). Keywords: Villforth, BMD.
• Washington Wrap-up: Wayne Pines dismissed, Larry Oster (MDDI, Aug 1982, p. 16). Keywords: Political Influence, Management.
• Washington Wrap-up: BMD loses the lead, Larry Oster (MDDI, Jun 1982, p. 14). Keywords: BMD, Bureau Of Biologics, BRH.
• Washington Wrap-up: Panel reversed, Larry Oster (MDDI, Apr 1982, p. 72). Keywords: X-Ray Systems, Advisory Panels.
• Washington Wrap-up: Coherency, Larry Oster (MDDI, Jan 1982, p. 17). Keywords: Publications/Presentations, BMD.

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1981

• Year in review: uncertain moves from a new administration, Jim Phelps (MDDI, Dec 1981, p. 21). Keywords: Professional Licensing, Cost Containment, BMD.
• Washington Wrap-up: Mary Bruch discharged, Larry Oster (MDDI, Dec 1981, p. 12). Keyword: Personnel.
• Washington Wrap-up: Hayes's other views, Larry Oster (MDDI, Nov 1981, p. 19). Keywords: Hayes, BMD.
• Washington Wrap-up: Whither OSMA?, Larry Oster (MDDI, Nov 1981, p. 16). Keywords: DSMA, Small Business.
• Establishing good relations with the district office, Thomas H. Riggs (MDDI, Oct 1981, p. 26). Keywords: Regulatory Affairs, Compliance, District Offices.
• Washington Wrap-up: FDA authority stripped?, Larry Oster (MDDI, Sep 1981, p. 21). Keyword: Management.
• Washington Wrap-up: Gutted bureaucracy? (A), Larry Oster (MDDI, Sep 1981, p. 17). Keywords: Deregulation, Personnel.
• Washington Wrap-up: Zafra in hot water, Larry Oster (MDDI, Aug 1981, p. 19). Keyword: BMD.
• Washington Wrap-up: Discretionary FDA travel..., Larry Oster (MDDI, Jul 1981, p. 43). Keywords: Budget Cuts, Assistance.
• Washington Wrap-up: Hayes and devices, Larry Oster (MDDI, Jul 1981, p. 14). Keyword: Hayes.
• Rare opportunity for Hayes (A), Jim Phelps (MDDI, Jun 1981, p. 21). Keywords: Hayes, Clinical Investigations, Personnel.
• Washington Wrap-up: FDA's new commissioner, Larry Oster (MDDI, May 1981, p. 68). Keywords: Hayes, Management.
• Washington Wrap-up: Jere Goyan resigns, Larry Oster (MDDI, Apr 1981, p. 18). Keywords: Management, Goyan.
• Washington Wrap-up: Politics in device approvals, Larry Oster (MDDI, Feb 1981, p. 12). Keywords: Government Criticism, Management.
• New FDA leadership (The): will industry be heard?, Larry R. Pilot (MDDI, Feb 1981, p. 8). Keywords: Forecasts, Management.
• Interview with FDA's Jere Goyan (An), Larry Oster (MDDI, Jan 1981, p. 53). Keywords: BMD, Management.

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1980

• Washington Wrap-up: More help for small business, Larry Oster (MDDI, Dec 1980, p. 15). Keywords: BMD, Small Business, Product Approval.
• Washington Wrap-up: Conflict of interest, Larry Oster (MDDI, Dec 1980, p. 15). Keyword: Personnel.
• Washington Wrap-up: BMD under seige, Larry Oster (MDDI, Dec 1980, p. 13). Keywords: Ob/Gyn Devices, BMD.
• Washington Wrap-up: More clout for OSMA, Larry Oster (MDDI, Nov 1980, p. 18). Keywords: Small Manufacturers, BMD.
• BMD and current regulatory issues, George F. Smith (MDDI, Oct 1980, p. 20). Keywords: BMD, Industry Opinion.
• BMD update, Victor Zafra (MDDI, Oct 1980, p. 8). Keyword: BMD.
• Washington Wrap-up: BMD Director David Link..., Larry Oster (MDDI, Jul 1980, p. 14). Keyword: Personnel.
• Washington Wrap-up: Can FDA be speeded up?, Larry Oster (MDDI, Jul 1980, p. 14). Keyword: Personnel.
• Washington Wrap-up: Larry Pilot's old job..., Larry Oster (MDDI, May 1980, p. 21). Keyword: Personnel.
• Parting thoughts of David M. Link (The), Larry Oster (MDDI, Apr 1980, p. 38). Keyword: Personnel.
• Washington Wrap-up: Another significant change..., Larry Oster (MDDI, Mar 1980, p. 60). Keyword: Personnel.
• Washington Wrap-up: Strongly consumerist... (A), Larry Oster (MDDI, Mar 1980, p. 60). Keyword: Personnel.
• Washington Wrap-up: Goyan a boon to consumerists, Larry Oster (MDDI, Feb 1980, p. 12). Keywords: Goyan, Personnel.
• BMD standards endorsement: a cause for concern, Edward Kimmelman (MDDI, Feb 1980, p. 8). Keywords: BMD, Standards.
• Washington Wrap-up: Ethylene oxide sterilization..., Larry Oster (MDDI, Jan 1980, p. 12). Keywords: Et O, Sterilization, BMD.

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1979

• BRH and medical device regulation, Robert G. Britain (MDDI, Dec 1979, p. 20). Keywords: Radiation Control Act, Amendments, BRH.
• Washington Wrap-up: FDA's new commissioner,..., Larry Oster (MDDI, Dec 1979, p. 13). Keyword: Personnel.
• We are from the government, and we are here to help you!, H. Neal Dunning (MDDI, Dec 1979, p. 8). Keywords: DSMA, Small Business.
• Medical device standards, Eldon E. Frisch (MDDI, Oct 1979, p. 42). Keywords: Advisory Committees, Standards.
• Washington Wrap-up: Larry Pilot's old job..., Larry Oster (MDDI, Sep 1979, p. 47). Keyword: Personnel.
• Washington Wrap-up: FDA changes its mind, Larry Oster (MDDI, Sep 1979, p. 46). Keywords: Skin-Test Antigens, Bureau Of Biologics.
• Washington Wrap-up: Small-business assistance..., Larry Oster (MDDI, Sep 1979, p. 12). Keywords: Small Business, Assistance.
• Washington Wrap-up: Joe Califano promised..., Larry Oster (MDDI, Sep 1979, p. 12). Keyword: Personnel.
• Washington Wrap-up: Rampant apathy?, Larry Oster (MDDI, Aug 1979, p. 11). Keywords: Advisory Panels, Regulatory Climate.
• Washington Wrap-up: Those to whom hope springs eternal..., Larry Oster (MDDI, Jul 1979, p. 13). Keyword: Management.
• Industry News: Pilot resigns (MDDI, Jun 1979, p. 24). Keywords: Compliance, Personnel.
• Washington Wrap-Up: Is FDA ungovernable?, Larry Oster (MDDI, Jun 1979, p. 16). Keywords: Management, Kennedy.

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