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MDDI Page | Category Index

Medical Device & Diagnostic Industry
Articles by Category - Legal Affairs

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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2002

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2001

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2000

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1999

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1998

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1997

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1996

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1995

  • (Washington Wrap-Up) FDA Loses in Preemption Case, James G. Dickinson (MDDI, Dec 1995, p. 38). Keyword: Preemption.
  • The Federal Preemption Defense to Product Liability Suits, Daniel G. Jarcho (MDDI, May 1995, p. 68). Keyword: Liability.
  • (Washington Wrap-Up) FDA Supports State Tort Actions, James G. Dickinson (MDDI, Apr 1995, p. 30). Keyword: Preemption.
  • (Washington Wrap-Up) Two More Blows against Tort Preemption, James G. Dickinson (MDDI, Feb 1995, p. 46). Keyword: Preemption.
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1994

  • (Washington Wrap-Up) Courts in Conflict on Device Preemption Law, James G. Dickinson (MDDI, Dec 1994, p. 26). Keyword: Preemption.
  • (Washington Wrap-Up) Bleak Outlook for Innovation?, James G. Dickinson (MDDI, Sep 1994, p. 34). Keyword: Liability.
  • (Washington Wrap-Up) Fixing the Liability Laws, James G. Dickinson (MDDI, Aug 1994, p. 26). Keyword: Liability.
  • (Washington Wrap-Up) FDA Supreme over Lay Juries, James G. Dickinson (MDDI, Jul 1994, p. 34). Keyword: Liability.
  • (Washington Wrap-Up) Press Use of FDA Report Spurs Suit against Bard, James G. Dickinson (MDDI, Jun 1994, p. 48). Keyword: Liability.
  • (Interview) Reforming Medical Device Liability, William Griffin (MDDI, May 1994, p. 110). Keyword: Liability.
  • (News) Medical Coalition Launches New Offensive to Reform Liability System (MDDI, May 1994, p. 28). Keyword: Liability.
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1993

  • Raw Deal (A), John Bethune (MDDI, Jul 1993, p. 8). Keywords: Product Liability.
  • Face to Face: Does the PMA Process Offer Product Liability Protection?: An Interview with Joseph Leghorn, Partner, Warren & Stackpole, Boston, Joseph Leghorn (MDDI, Apr 1993, p. 38). Keywords: Product Liability.
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1992

  • Who really owns your software?, Stephen Glazier (MDDI, May 1992, p. 32). Keywords: Contracts, Patenting, Software Patenting.
  • Lengthy patent terms stifle innovation, Ronald E. Lund (MDDI, Apr 1992, p. 18). Keywords: Patent Term Extension, Innovation, Patents.
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1991

  • Medical software patents: new developments, Stephen Glazier (MDDI, Oct 1991, p. 46). Keywords: Patent Licensing, Patenting, Patents.
  • Washington Wrap-up: More FDA saber rattling, James G. Dickinson (MDDI, Jul 1991, p. 20). Keyword: FDAEnforcement.
  • Good guys, bad guys, and device reviews, William D. Appler (MDDI, Mar 1991, p. 32). Keywords: Policy, FDAEnforcement.
  • Medicare coverage for technology: new dimensions from the courts and Congress, Gordon B. Schatz (MDDI, Mar 1991, p. 26). Keyword: Reimbursement.
  • Washington Wrap-up: Debarment bill unnecessary?, James G. Dickinson (MDDI, Mar 1991, p. 21). Keywords: FDAEnforcement, Legislation.
  • Washington Wrap-up: Goodbye, presubmission review, James G. Dickinson (MDDI, Feb 1991, p. 68). Keyword: FOI.
  • Implications of the Safe Medical Devices Act of 1990 (The), Jonathan S. Kahan (MDDI, Feb 1991, p. 44). Keywords: FDAEnforcement, Safe Medical Devices Act, Regulatory Affairs.
  • Getting the most from your patents, Barbara J. Luther (MDDI, Jan 1991, p. 46). Keywords: Patent Term Extension, Patents.
  • Who bears the responsibility when device companies violate the law?, William D. Appler (MDDI, Jan 1991, p. 38). Keyword: FDAEnforcement.
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1990

  • Washington Wrap-up: New fraud policy, James G. Dickinson (MDDI, Dec 1990, p. 25). Keywords: Policy, FDAEnforcement.
  • Medical device lawsuits: lessons from the claims file, Kevin M. Quinley (MDDI, Oct 1990, p. 56). Keywords: Insurance, Product Liability, Risk Management.
  • Noninfringing sales of an infringing medical device: Lilly v. Medtronics, Michael J. Ram (MDDI, Sep 1990, p. 36). Keyword: Patents.
  • Washington Wrap-up: FDA debarments?, James G. Dickinson (MDDI, Aug 1990, p. 34). Keywords: FDAEnforcement, Legislation.
  • Medical device competitors: playing on a level field, Jeffrey N. Gibbs (MDDI, Jun 1990, p. 105). Keywords: Unfair Competition, Lanham Act, FDAEnforcement.
  • Extra-label usage: an open secret, Jonathan S. Kahan (MDDI, Apr 1990, p. 47). Keywords: Product Liability, FDARegulation, Extra-Label Usage.
  • Enforcement review, 1989, William D. Appler (MDDI, Apr 1990, p. 30). Keyword: FDAEnforcement.
  • Washington Wrap-up: Clark Research attorney sanctioned, James G. Dickinson (MDDI, Apr 1990, p. 28). Keyword: FDAEnforcement.
  • Washington Wrap-up: FDA criminal powers come home, James G. Dickinson (MDDI, Apr 1990, p. 26). Keywords: FDAEnforcement, Trade Secrets, Government Relations.
  • FDA appeals process (The), William D. Appler (MDDI, Feb 1990, p. 30). Keywords: Adverse Decisions, Appeals.
  • Washington Wrap-up: Safe custody of trade secrets, James G. Dickinson (MDDI, Feb 1990, p. 26). Keywords: Trade Secrets, FOI.
  • News: Supreme Court to rule on Lilly case (MDDI, Feb 1990, p. 20). Keyword: Patents.
  • News: Hazard analysis minimizes liability (MDDI, Feb 1990, p. 18). Keywords: Product Liability, Safety, Hazard Analysis.
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1989

  • Washington Wrap-up: Hurrying up FDA, Larry Oster (MDDI, Dec 1989, p. 32). Keywords: Ob/Gyn Devices, Standards, Labeling.
  • D&O insurance: board games for device companies, Kevin M. Quinley (MDDI, Oct 1989, p. 64). Keywords: Insurance, D&OLiability.
  • Washington Wrap-up: Clark Research loses again, Larry Oster (MDDI, Oct 1989, p. 49). Keywords: FDAEnforcement, Product Approval.
  • FDA Notes: Elsewhere in court, William D. Appler (MDDI, Oct 1989, p. 37). Keywords: Regulatory Letter.
  • FDA Notes: Notes from the courthouse, William D. Appler (MDDI, Oct 1989, p. 36). Keyword: Inspections.
  • Washington Wrap-up: Us against them, part II, Larry Oster (MDDI, Aug 1989, p. 36). Keywords: Advisory Committees, Personnel.
  • Washington Wrap-up: Us against them, part I, Larry Oster (MDDI, Aug 1989, p. 34). Keyword: FDAEnforcement.
  • Washington Wrap-up: 'Intended' use, Larry Oster (MDDI, May 1989, p. 32). Keywords: FDAEnforcement, Classification.
  • Washington Wrap-up: 'Gotcha!' syndrome (The), Larry Oster (MDDI, May 1989, p. 26). Keywords: FDAEnforcement, 510(k)s.
  • Rationality and FDA litigation, William D. Appler (MDDI, Feb 1989, p. 16). Keyword: FDAEnforcement.
  • Preparing an invention disclosure, Iver P. Cooper (MDDI, Jan 1989, p. 108). Keywords: Invention Disclosure, Patents.
  • What to expect from your liability defense lawyer, Kevin M. Quinley (MDDI, Jan 1989, p. 104). Keywords: Product Liability, Risk Management, Lawyers.
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1988

  • Washington Wrap-up: Cordis prosecution, Larry Oster (MDDI, Nov 1988, p. 88). Keywords: FDAEnforcement, Electronic Devices, Cardiovascular Devices.
  • Washington Wrap-up: Laboratory bill, Larry Oster (MDDI, Sep 1988, p. 40). Keyword: Laboratories.
  • Washington Wrap-up: Tampon ratings, Larry Oster (MDDI, Sep 1988, p. 38). Keywords: Ob/Gyn Devices.
  • Washington Wrap-up: Reclassification woes, Larry Oster (MDDI, Sep 1988, p. 38). Keyword: Reclassification.
  • News: Liability case troubles industry, David Haut (MDDI, Sep 1988, p. 28). Keywords: Product Liability.
  • Campaign '88: interviews with the candidates' health policy advisors, David Haut (MDDI, Sep 1988, p. 18). Keywords: Political Influence, Legislation.
  • Washington Wrap-up: Post-mortem on BioClinical case, Larry Oster (MDDI, Jul 1988, p. 24). Keyword: FDAEnforcement.
  • News: HIDA fights product diversion: asks manufacturers to help, Marni Bell (MDDI, Jul 1988, p. 16). Keywords: Distribution, Product Diversion.
  • Clinical Research Q&A, Maria M. Koretz (MDDI, Jun 1988, p. 150). Keywords: IRBs, Informed Consent, Clinical Investigations.
  • Guilty: home-use IVDs: avoiding liability, Jonathan S. Kahan (MDDI, Jun 1988, p. 65). Keywords: Diagnostics, Product Liability.
  • Defending against product liability, Kathleen Doheny (MDDI, Jun 1988, p. 58). Keywords: Product Liability.
  • Washington Wrap-up: When government abuses, Larry Oster (MDDI, Jun 1988, p. 44). Keywords: Diagnostics, FDAEnforcement.
  • Washington Wrap-up: Experts disagree, Larry Oster (MDDI, Apr 1988, p. 16). Keywords: FDAEnforcement, Compliance.
  • Washington Wrap-up: More about BioClinical, Larry Oster (MDDI, Apr 1988, p. 14). Keywords: FDAEnforcement, Compliance.
  • News: House product liability bill moves forward despite infighting (MDDI, Mar 1988, p. 49). Keywords: Legislation, Product Liability.
  • Biotechnology Dialogue: United States signs free trade agreement with Canada, Bruce F. Mackler (MDDI, Feb 1988, p. 26). Keywords: International Trade.
  • Washington Wrap-up: Some product liability advice, Larry Oster (MDDI, Feb 1988, p. 18). Keywords: Product Liability.
  • Washington Wrap-up: Learning what not to say in court, Larry Oster (MDDI, Feb 1988, p. 18). Keywords: Product Liability.
  • Guidelines aren't regulations (and other lessons from the federal courts), William D. Appler (MDDI, Feb 1988, p. 10). Keywords: FDAEnforcement, Guidelines.
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1987

  • Washington Wrap-up: Novel use of the petition process (A), Larry Oster (MDDI, Dec 1987, p. 14). Keyword: Labeling.
  • Minimizing product liability exposure in device labeling, Bruce F. Mackler (MDDI, Nov 1987, p. 28). Keywords: Product Liability, Labeling.
  • Washington Wrap-up: Suntanning controversy pits federal versus town law, Larry Oster (MDDI, Oct 1987, p. 18). Keyword: Sunlamp.
  • Protecting trade secrets from departing employees, Bernard E. O'Connor, Jr. (MDDI, Sep 1987, p. 40). Keywords: Trade Secrets, Proprietary Information.
  • Biotechnology Dialogue: FDA GMP inspectional guidelines found unenforceable, Bruce F. Mackler (MDDI, Sep 1987, p. 22). Keywords: Guidelines, FDAEnforcement.
  • ALZA's Peter Carpenter; Product liability: an integral part of doing business, David Haut (MDDI, Jul 1987, p. 20). Keywords: Product Liability, Risk Management.
  • Medical device claims: managing your insurer, Kevin M. Quinley (MDDI, Jun 1987, p. 148). Keywords: Insurance, Product Liability, Risk Management.
  • Biotechnology Dialogue: Update on Hybritech, Inc. v. Monoclonal Antibodies, Inc., Bruce F. Mackler (MDDI, Jun 1987, p. 37). Keyword: Biotechnology.
  • Washington Wrap-up: Easing tort concerns, Larry Oster (MDDI, Jun 1987, p. 22). Keywords: Product Liability.
  • Biotechnology Dialogue: Antibody-sandwich-assay patent conflict: Monoclonal Antibodies v. Hybritech, Bruce F. Mackler (MDDI, May 1987, p. 26). Keyword: Biotechnology.
  • In confidence, with confidence, Iver P. Cooper (MDDI, Mar 1987, p. 36). Keywords: Confidentiality Agreements, Trade Secrets.
  • HR 5516: much-needed reform, Henry A. Waxman (MDDI, Jan 1987, p. 12). Keywords: Legislation, Product Approval.
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1986

  • Product liability: reducing risks in design and manufacture, Mohan N. Joshi (MDDI, Nov 1986, p. 46). Keywords: Design Review, Product Liability, Risk Management.
  • Putting new life into your medical device patents, Iver P. Cooper (MDDI, Oct 1986, p. 58). Keywords: Patent Term Extension, Patents.
  • Reuse: product liability issues, Nina Novak (MDDI, Oct 1986, p. 10). Keywords: Product Liability, Reuse.
  • Investigational devices: the commercialization controversy, Jonathan S. Kahan (MDDI, Sep 1986, p. 52). Keywords: Guidelines, Commercialization, Clinical Investigations.
  • Biotechnology Dialogue: US patent office guidelines for deposits of biological material, Bruce F. Mackler (MDDI, Sep 1986, p. 29). Keywords: Biological Material, Patents.
  • Washington Wrap-up: Physician incompetence to be addressed?, Larry Oster (MDDI, Aug 1986, p. 16). Keywords: Product Liability.
  • Communications and product liability, Wayne L. Pines (MDDI, Jun 1986, p. 138). Keywords: Public Relations, Product Liability.
  • Biotechnology Dialogue: New biotechnology legislation proposed, Bruce F. Mackler (MDDI, Jun 1986, p. 39). Keywords: Legislation, Biotechnology.
  • Mark my words ... and your patented device, Iver P. Cooper (MDDI, Jun 1986, p. 32). Keyword: Patents.
  • When FDA won't enforce the law, Jim Phelps (MDDI, Apr 1986, p. 51). Keyword: FDAEnforcement.
  • Criminal Fine Enforcement Act: unbearable risk?, Jim Phelps (MDDI, Mar 1986, p. 33). Keywords: Product Liability, Penalties, Criminal Fine Enforcement Act.
  • Biotechnology Dialogue: Biosafety bill proposes to regulate use of recombinant DNA organisms in all manufacturing, Bruce F. Mackler (MDDI, Mar 1986, p. 32). Keywords: Genetic Engineering, Legislation, Biotechnology.
  • Biotechnology Dialogue: National Cancer Institute and Institut Pasteur in dispute over who deserves rewards of AIDS research, Bruce F. Mackler (MDDI, Mar 1986, p. 30). Keywords: AIDSResearch, Patents.
  • Biotechnology Dialogue: Export of unapproved biologics and drugs, Bruce F. Mackler (MDDI, Mar 1986, p. 28). Keywords: Legislation, Biologics, Exports.
  • Biotechnology Dialogue: Controversy over regulatory jurisdiction of in vitro diagnostics, Bruce F. Mackler (MDDI, Mar 1986, p. 28). Keywords: Diagnostics, Legislation.
  • Washington Wrap-up: Defeat for delay (A), Larry Oster (MDDI, Feb 1986, p. 16). Keywords: Regulations, FOI.
  • New product liability law in Europe: U.S. manufacturers take note, Iver P. Cooper (MDDI, Jan 1986, p. 54). Keywords: Product Liability, EEC.
  • Biotechnology Dialogue: 'Research use' exemption for unapproved Class III devices, Bruce F. Mackler (MDDI, Jan 1986, p. 48). Keywords: Product Seizures, Research, Biotechnology.
  • Product liability: minimizing potential risk, Howard R. Asher (MDDI, Jan 1986, p. 8). Keywords: Product Liability, Risk Management.
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1985

  • Risk management: the role of the medical device autopsy, Ram Kossowsky (MDDI, Nov 1985, p. 33). Keywords: Product Liability, Device Autopsy, Risk Management.
  • Washington Wrap-up: Robins bankruptcy an industry lesson, Larry Oster (MDDI, Nov 1985, p. 18). Keywords: Product Liability.
  • Role of FDA device regulation in medical malpractice litigation (The), Jonathan S. Kahan (MDDI, Jul 1985, p. 40). Keywords: Medical Malpractice, Clinical Investigations.
  • Remedies for patent infringement, Iver P. Cooper (MDDI, Jun 1985, p. 60). Keyword: Patents.
  • Washington Wrap-up: R&D antitrust, Larry Oster (MDDI, Jun 1985, p. 35). Keyword: Antitrust.
  • Hazard communication: an appropriate response, Michael L. Rataj (MDDI, Jun 1985, p. 26). Keywords: Occupational Safety.
  • Washington Wrap-up: Mixed signals for biotechnology, Larry Oster (MDDI, Apr 1985, p. 20). Keyword: Biotechnology.
  • Washington Wrap-up: MDR and liability law, Larry Oster (MDDI, Apr 1985, p. 20). Keywords: MDR, Product Liability.
  • Washington Wrap-up: Young challenges lawyers, Larry Oster (MDDI, Feb 1985, p. 20). Keyword: FDAEnforcement.
  • Protecting your trademarks, Iver P. Cooper (MDDI, Jan 1985, p. 62). Keyword: Trademarks.
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1984

  • MDR: does it make a difference?, Jonathan S. Kahan (MDDI, Dec 1984, p. 10). Keywords: MDR, Product Liability.
  • Medical lasers and the law, Jonathan S. Kahan (MDDI, Nov 1984, p. 82). Keywords: Lasers, Radiation Control Act.
  • Washington Wrap-up: Device patent extension, Larry Oster (MDDI, Nov 1984, p. 16). Keywords: Legislation, Patents.
  • Washington Wrap-up: Historic hearing (An), Larry Oster (MDDI, Aug 1984, p. 18). Keywords: Product Approval, Cardiovascular Devices.
  • Washington Wrap-up: DRGs and antitrust, Larry Oster (MDDI, Jun 1984, p. 14). Keywords: DRGs, Antitrust.
  • Selecting a trademark for a new medical device, Iver P. Cooper (MDDI, May 1984, p. 30). Keyword: Trademarks.
  • Products liability and the FDA administrative record, Larry R. Pilot (MDDI, Jan 1984, p. 22). Keywords: Product Liability.
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1983

  • Patent office reexamination of medical device patents, Iver P. Cooper (MDDI, Nov 1983, p. 32). Keyword: Patents.
  • Responding to FDA regulatory letters, Jim Phelps (MDDI, Oct 1983, p. 28). Keywords: Regulatory Letters, FDAEnforcement.
  • Employment-at-will doctrine (The): minimizing the risks of litigation, Arthur F. Silbergeld (MDDI, Sep 1983, p. 18). Keywords: Employee Termination, Employment.
  • Washington Wrap-up: Raw data not trade secrets, Larry Oster (MDDI, Jul 1983, p. 14). Keywords: Trade Secrets, FOI.
  • Product liability law: changes ahead?, Jim Phelps (MDDI, Jun 1983, p. 28). Keywords: Product Liability.
  • Washington Wrap-up: OSHA given EtO marching orders, Larry Oster (MDDI, Jun 1983, p. 18). Keywords: Et O, Occupational Safety.
  • Preventing inadvertent forfeiture of patent rights, Iver P. Cooper (MDDI, Mar 1983, p. 70). Keyword: Patents.
  • Major contract issues in purchasing a computer system, Gilbert N. Kruger (MDDI, Mar 1983, p. 20). Keywords: Contracts, Computers.
  • Limited partnerships in research and development, Gilbert N. Kruger (MDDI, Jan 1983, p. 52). Keywords: Limited Partnerships, R&D, Financing.
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1982

  • Protecting trade secrets, Gilbert N. Kruger (MDDI, Nov 1982, p. 28). Keywords: Trade Secrets.
  • Mixed blessings at FDA hearing, Robert A. Dormer (MDDI, Oct 1982, p. 24). Keywords: Congressional Hearings, Legislation, Government Criticism.
  • Device manufacturing issues: a legislative update, Ted R. Mannen (MDDI, Sep 1982, p. 38). Keywords: Legislation, Regulatory Climate, HIMA.
  • Bringing down the barriers to high-technology trade, James M. Shannon (MDDI, Sep 1982, p. 10). Keywords: International Trade.
  • Implications of voluntary standards setting, Jim Phelps (MDDI, Aug 1982, p. 42). Keywords: Standards Setting, Standards.
  • Washington Wrap-up: Wesley-Jessen loses again, Larry Oster (MDDI, Jun 1982, p. 72). Keywords: Contact Lens.
  • Washington Wrap-up: One for FDA, Larry Oster (MDDI, May 1982, p. 17). Keywords: Contact Lens.
  • Manufacturer's role in user training (The), Joel Nobel (MDDI, May 1982, p. 10). Keywords: Instruction Manuals, Product Liability, End-Users.
  • Role of marketing and sales in corporate compliance (The), Larry R. Pilot (MDDI, Apr 1982, p. 35). Keywords: Marketing, Product Liability, Regulations.
  • Contesting adverse FDA decisions: is it worth the risk?, Robert A. Dormer (MDDI, Apr 1982, p. 26). Keywords: Adverse Decisions.
  • Restoring balance to the FOI Act, Orrin G. Hatch (MDDI, Mar 1982, p. 46). Keyword: FOI.
  • FTC regulation of medical device advertising, Thomas A. Donegan, Jr. (MDDI, Feb 1982, p. 19). Keywords: Advertising, FTC.
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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.
  • Criminal prosecutions and FDA inspections, Jim Phelps (MDDI, Aug 1981, p. 33). Keyword: Inspections.
  • Washington Wrap-up: FDA device seizures..., Larry Oster (MDDI, Jul 1981, p. 49). Keywords: Product Seizures.
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1980

  • More regulatory troubles brewing?, Jim Phelps (MDDI, Dec 1980, p. 18). Keyword: FDARegulation.
  • Regulation by rhetoric?, Jim Phelps (MDDI, Aug 1980, p. 16). Keyword: FDARegulation.
  • Patent protection for federally funded R&D, Birch Bayh (MDDI, Aug 1980, p. 10). Keyword: Patents.
  • Washington Wrap-up: 'Good' and other intentions:..., Larry Oster (MDDI, Jul 1980, p. 11). Keyword: FD&CAmendments.
  • Trade initiatives in the 1980s, Bill Roth (MDDI, Jul 1980, p. 8). Keywords: National Export Policy Act, Trade.
  • Competition in health care, David Durenberger (MDDI, Apr 1980, p. 8). Keywords: Health Incentives Reform Act, Finance.
  • Patenting medical devices: part II, W. Edward Johansen (MDDI, Jan 1980, p. 32). Keyword: Patents.
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1979

  • Patenting medical devices: part I, W. Edward Johansen (MDDI, Dec 1979, p. 24). Keyword: Patents.
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