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PMPN Page | Category Index

Pharmaceutical and Medical Packaging News
Articles by Category - Regulatory

2008 | 2006 | 2005 | 2002 | 2001 | 2000 | 1999 | 1998

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2008

• (RFID) Anteing Up for RFID, David Vaczek (PMPN, Jul 2008, p. 44). Keyword: Packaging.
• (Compliance Packaging) Compliance Packaging Tackles Chronic Illness and Cost Concerns, Maximillian Del Rey (PMPN, Jun 2008, p. 90). Keyword: Packaging.
• (Editorial) Don't Hesitate to Develop Child-Resistant, Senior-Friendly Compliance Packaging, Daphne Allen (PMPN, Jun 2008, p. 12). Keyword: Packaging.
• (Editorial) For the Global Good(s), Daphne Allen (PMPN, May 2008, p. 12). Keyword: Packaging.

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2006

• (Track and Trace) Authentication Before Track and Trace, Daphne Allen (PMPN, Feb 2006, p. 30). Keyword: Industry.
• (Track and Trace) RFID: The Benefits Are Here to Stay, Gregg Metcalf (PMPN, Jan 2006, p. 26). Keyword: Industry.

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2005

• (Track and Trace) Preparing for RFID Lift-Off, Stephanie Steward (PMPN, Dec 2005, p. 26). Keyword: Industry.
• (Track and Trace) Securing the Security System, Daphne Allen (PMPN, Nov 2005, p. 30). Keyword: Industry.
• (Track and Trace) Authenticating RFID, Daphne Allen (PMPN, Oct 2005, p. 30). Keyword: Industry.
• (Regulatory Focus) Pinning Down New Label Rules, David Vaczek (PMPN, Sep 2005, p. 26). Keyword: Labeling.

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2002

• (Regulatory Focus) Labeling Update for Generic OTC Drugs, Erik Swain (PMPN, Dec 2002, p. 18). Keyword: Labeling.
• (News) GMPs for Dietary Supplements, Erik Swain (PMPN, Dec 2002, p. 12). Keyword: Industry.
• (Our View) How to Ensure Good Manufacturing Practices, J. Michael McKay (PMPN, Nov 2002, p. 22). Keyword: Industry.
• (Regulatory Focus) For the (Electronic) Record, Erik Swain (PMPN, Nov 2002, p. 24).
• (News) Combination Products No Longer Reviewed by CBER, Erik Swain (PMPN, Nov 2002, p. 16). Keyword: Industry.
• (Our View) Expiration Dating for Unit-Dose Repackagers, Eugene Peiser (PMPN, Oct 2002, p. 22). Keyword: Repackaging.
• (Regulatory Focus) A CGMP Makeover, Erik Swain (PMPN, Oct 2002, p. 20).
• (News) Draft Guidance for Liposomes, Erik Swain (PMPN, Oct 2002, p. 16). Keyword: Industry.
• (Regulatory Focus) Applications for nasal sprays and inhalants must meet criteria in FDA document, Erik Swain (PMPN, Sep 2002, p. 22).
• (Special) Discussing Drug Master Files (PMPN, Sep 2002, p. 44).
• (Regulatory Focus) European standard beefs up child-resistance testing of nonreclosable packages, Erik Swain (PMPN, Jul 2002, p. 20). Keyword: Testing.
• (News) 21 CFR Part 11 Takes Center Stage at Interphex, Erik Swain (PMPN, Jul 2002, p. 14).
• (Spotlight) The Future of Paper Inserts, Erik Swain (PMPN, Jul 2002, p. 26). Keyword: Materials.
• (Regulatory Focus) FDA cites speed and accuracy as benefits of electronic submissions for labeling, Erik Swain (PMPN, Jun 2002, p. 22).
• (Regulatory Focus) 510(k)s for Medical Sterilization Packaging, Erik Swain (PMPN, May 2002, p. 20).
• (News) Drug Master File Workshop, Erik Swain (PMPN, May 2002, p. 12).
• (Regulatory Focus) Label Claims for Supplements, Erik Swain (PMPN, Mar 2002, p. 24).

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2001

• (Our View) Special Packaging Reduces Child Death Rate, Geri Smith (PMPN, Dec 2001, p. 14). Keyword: Industry.
• (Regulatory Focus) New Guidance on Geriatric Labeling (PMPN, Dec 2001, p. 78).
• (Regulatory Focus) Centrally Filled Controlled Substances (PMPN, Nov 2001, p. 78).
• (Regulatory Focus) CR Packaging for OTC Switches, Suzanne Barone (PMPN, Oct 2001, p. 78). Keyword: Labeling.
• (Regulatory Focus) Survival of the Fittest Drug Label (PMPN, Sep 2001, p. 74). Keyword: Labeling.
• (Regulatory Focus) FDA Revisits Reprocessed Device Issue (PMPN, Jul 2001, p. 74).
• (Regulatory Focus) FDA Puts a Leash on Stability Testing (PMPN, Jun 2001, p. 90).
• (Regulatory Focus) FDA Clarifies Postapproval Changes (PMPN, May 2001, p. 86).
• (Editorial) FDA Inspections 101, Daphne Allen (PMPN, Apr 2001, p. 8).
• (Regulatory Focus) Streamlining the Inspection Process (PMPN, Apr 2001, p. 98).
• (Regulatory Focus) FDA Caters to Physicians, Nancy Ostrove (PMPN, Mar 2001, p. 130).
• (Regulatory Focus) FDAMA Makes Favorable Progress (PMPN, Jan 2001, p. 74). Keyword: FDAMA.

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2000

• (Regulatory Focus) New Criteria for Disease-Related Claims on Dietary Supplement Labels (PMPN, Dec 2000, p. 96). Keyword: Labeling.
• (Regulatory Focus) New Physician Labeling to Be Required for Antibiotics (PMPN, Nov 2000, p. 74). Keywords: Labeling, Antibiotics.
• (Regulatory Focus) CPSC Proposes Child-Resistant Packaging for Certain OTC Drugs (PMPN, Oct 2000, p. 90).
• New Requirements for Drugs in Cold Storage and Drugs in Semipermeable Packaging (PMPN, Jul 2000, p. 78). Keywords: Regulatory Focus.
• Dispensing Trial Drugs for Home Use, Geri Niebauer (PMPN, Jul 2000, p. 16). Keywords: Our View.
• (Regulatory Focus) ASTM Reorganizes Its Packaging Committee (PMPN, Jun 2000, p. 10).
• (Regulatory Focus) New Format For Device Labeling (PMPN, May 2000, p. 98). Keyword: Labeling.
• (Regulatory Focus) FDA Issues Rule on Aluminum in Parenteral Packaging (PMPN, Apr 2000, p. 98). Keyword: Parenteral.
• (Regulatory Focus) New Labeling Guidance for OTC Drug Testing Kits (PMPN, Mar 2000, p. 114). Keyword: Labeling.
• (Regulatory Focus) Rules Relaxed for Changes (PMPN, Feb 2000, p. 82). Keyword: CDER.
• (Regulatory Focus) Accelerated Aging Protocols Established (PMPN, Jan 2000, p. 86). Keyword: Testing.

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1999

• (Regulatory Focus) Disease Claims for Nutraceuticals (PMPN, Dec 1999, p. 102). Keyword: Labeling.
• (Medical Focus) Medical Packaging Roundtable: Managing ISO 11607 (PMPN, Dec 1999, p. 60). Keyword: Sterilization.
• (Regulatory Focus) FDA Proposes New Monograph for Otic Drugs (PMPN, Nov 1999, p. 82). Keywords: OTC Drugs.
• (Regulatory Focus) Policy for Clinical Trial Packaging Takes Shape (PMPN, Oct 1999, p. 86). Keywords: Clinical Trials.
• (Q&A) FDA Explains Labeling Regulations (PMPN, Oct 1999, p. 22). Keyword: Labeling.
• (Regulatory Focus) NDAs Require Packaging Data (PMPN, Sep 1999, p. 67). Keywords: New Drug Applications.
• (Regulatory Focus) FDA Proposes to Delete Warning Label on Hormone (PMPN, Jul 1999, p. 67). Keyword: Labeling.
• (Regulatory Focus) ISTA Issues Thermal Packaging Guideline (PMPN, Jun 1999, p. 102). Keywords: Temperature Control.
• (Regulatory Focus) FDA Finalizes OTC Labeling Format (PMPN, May 1999, p. 86). Keyword: Labeling.
• (Regulatory Focus) Guidance for Geriatric Labeling (PMPN, Apr 1999, p. 114). Keyword: Labeling.
• (Our View) Global Harmonization (PMPN, Apr 1999, p. 20). Keyword: Standards.
• (Regulatory Focus) ASTM Standard Aims to Increase Pallet Reuse (PMPN, Mar 1999, p. 90). Keyword: ASTM.

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1998

• Robot Safety Standards to Improve (PMPN, Dec 1998, p. 94). Keyword: Safety.
• Revisions to CR Packaging Rules (PMPN, Nov 1998, p. 98). Keywords: Regulatory Focus.
• Industry Seeks Changes to OTC Labeling Reform (PMPN, Oct 1998, p. 82). Keyword: Labeling.

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