Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 19-20, 2004

Briefing Information

Introduction Memorandum to the Committee From Dr. Ajaz Hussain, PhD (HTM) (PDF) (Word)

Draft Agenda (HTM) (PDF) (Word)

Innovation or Stagnation - Challenge and Opportunity on the Critical Path to New Medical Products (Word)

Innovation and Continuous Improvement in Pharmaceutical Manufacturing - Pharmaceutical CGMPs for the 21st Century, The PAT Team and Manufacturing Science Workgroup (HTM) (PDF) (Word)

Concept and Criteria of BioINequivalence (HTM) (PDF) (Word)

Bioequivalence Testing for Locally Acting Gastrointestinal Drugs (HTM) (PDF) (Word)

Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach, Final Report (PDF)

Bibliography (HTM) (PDF) (Word)