ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
July 19-20, 2001
Briefing Information
June 19, 2001 Letter from Helen Winkle, Acting Director, Office of Pharmaceutical Science, FDA to Members, Advisory Committee for Pharmaceutical Science pdf htm
Notice of Meeting, 66FR32359 June 14, 2001 pdf htm
July 2001, Statement to Advisory Committee for Pharmaceutical Science and OINDP Subcommittee On the Work of the ITFG/IPAc-RS Collaboration Regarding Chemistry, Manufacturing, and Controls and In Vitro and In Vivo Bioavailability/Bioequivalence Issues in Draft Guidance Documents for Orally Inhaled and Nasal Drugs Products pdf htm
Bibliography of additional briefing information pdf htm
July 19, 2001
Session: Nonclinical Studies Subcommittee
Nonclinical Studies Subcommittee Advisory Committee on Pharmaceutical Science Background Information pdf htm
Session: Chemistry, Manufacturing and Controls
American Association of Pharmaceutical Scientists (AAPS)
Workshop - Streamlining the CMC Regulatory Process NDAs and ANDAs brochure, June
11-13, 2001 pdf
Drug Substance Risk Assessment - Report from Breakout Session, AAPS pdf
Workshop, June 12, 2001
Day 2- 9 Product Breakouts, AAPS Workshop, June 11-13, 2001 pdf
Summary of Comments from Sterile Drug Products and Drug Substances Break Out Sections, AAPS Workshop, June 11, 2001 pdf
AAPS Workshop on Streamlining the CMC Regulatory Process - Microbiology Breakout Sessions Summary, June 13, 2001 pdf
Risk-based CMC Review, GMP Breakout Sessions Summary, AAPS
Workshop,
June 11-13, 2001 pdf
July 20, 2001
Session: Clinical Pharmacology
ACPS (July 20 2001) Questions for Drug Transfer into Breast Milk pdf htm
Advisory Committee of Pharmaceutical Science, Drug Transfer
into Breast Milk:
Nonclinical and Clinical Methods, July 20, 2001 ppt
htm
Session: Complex Drug Substances-Liposome Drug Products
Liposomes: Critical Formulation Parameters, AAPS Workshop, June 11-13, 2001 pdf
Regulatory Science of Liposome Drug Products, Office of Testing and Research, CDER, FDA, June 28, 2001 ppt htm