Working Groups
Chair(s) |
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FDA Guidance/Regulation Impacted |
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RFID
Robert Seevers and Toby Massa |
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Future FDA RFID guidance |
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Container/Closure Systems
Daniel Malinowski |
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Draft Guidance for Industry Stability Testing of Drug Substances and Drug Products (Draft June 1998)
http://www.fda.gov/cder/guidance/1707dft.pdf
Final Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999)
http://www.fda.gov/cder/guidance/1714fnl.pdf
Final Guidance for Industry Changes to an Approved NDA and ANDA (November 1999) http://www.fda.gov/cder/guidance/2766fnl.pdf |
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Excipients
Robert Wiens |
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Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information (2003) ,http://www.fda.gov/cder/guidance/1215dft.pdf
FDA Guidance on Testing of Glycerine (2007), www.fda.gov/cder/guidance/index.htm. |
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Particle Size Distribution:
Mass Balance
Bruce Wyka and Terry Tougas |
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Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documents (1998).
http://www.fda.gov/cder/guidance/2180dft.pdf
Final Guidance for Industry-Nasal Spray Drug Products Chemistry, Manufacturing, and Control Documentation (2002)
http://www.fda.gov/cder/guidance/4234fnl.pdf |
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Particle Size Distribution:
Profile Comparison
David Christopher |
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Draft Guidance for Industry-Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (1999, second draft 2003)
http://www.fda.gov/cder/guidance/5383DFT.doc
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Leachables and Extractables
Daniel Norwood |
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Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documents (1998).
http://www.fda.gov/cder/guidance/2180dft.pdf
Final Guidance for Industry-Nasal Spray Drug Products Chemistry, Manufacturing, and Control Documentation (2002)
http://www.fda.gov/cder/guidance/4234fnl.pdf
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Specifications
Angelos Dovletoglou |
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Future FDA BACPAC Guidance
(Guidance for Industry BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation http://www.fda.gov/cder/guidance/3629fnl.htm )
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| Physical Attributes/ Particle Size of API
Sharon Snorek |
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ICH Q2A http://www.fda.gov/cder/guidance/ichq2a.pdf
ICH Q2B http://www.fda.gov/cder/guidance/1320fnl.pdf
ICH Q6A http://www.fda.gov/OHRMS/DOCKETS/98fr/122900d.pdf
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Impurities
Chun Chow Chan |
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ICH Q3A http://www.fda.gov/cder/guidance/Q3Cfnl.pdf
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