ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

November 15, 2000

Slides

314.70 Update, Nancy Sager   ppt   html

CMC Initiative: Risk-Based CMC Reviews, Yuan-yuan Chiu, PhD   ppt  html

PhRMA Perspective on Risk Based CMC Review of Manufacturing Changes, Tobia Massa, PhD  ppt   html

Risk-Based CMC Review:  A Generic Pharmaceutical Perspective, Deborah Miren  pdf

Subcommittee Report: Orally Inhaled and Nasal Drug Products (OINDP), Wallace P Adams, PhD   ppt   html

Dose Content Uniformity Issues, Guirag Poochikian, PhD  ppt   html

Nonclinical Studies Subcommittee, John Doull, MD, PhD  ppt   html

Overview of ITFG/IPAC-RS Collaboration for Presentation to the Advisory Committee For Pharmaceutical Science   ppt   html

Harris Cummings, PhD
Les Harrison, PhD
Bo Olsson PhD
Carole Evans, PhD
Gordon Hansen
Cynthia Blynn PhD

Letter dated November 6, 2000 to Nancy Chamberlin from the Inhalation Technology Focus Group (ITFG)  pdf