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

Bibliography   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Regarding Chemistry, Manufacturing, and Controls and In Vitro and In Vivo Bioavailability/Bioequivalence Issues in Draft Guidance Documents for Orally Inhaled and Nasal Drugs Products    pdf   htm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