Food and Drug Administration

Advisory Committee for Pharmaceutical Science

April 13-14, 2004

Briefing Information

Memorandum Regarding ACPS Meeting April 13-14, 2--4, Dr. Ajaz Hussain, PhD, FDA (HTM) (PDF) (Word)

Training of the FDA PAT Team (HTM) (PDF) (Word)

Rapid Microbiology Methods Update - Background (HTM) (PDF) (Word)

Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (PDF)

ASTM E55 Committee Overview (HTM) (PDF) (Word)

PAT Collaborations (HTM) (PDF) (Word)

Bioequivalence Requirements for Highly Variable Drugs and Drug Products (HTM) (PDF) (Word)

Criteria for Establishing Bio-Inequivalence Between Two Drug Products (HTM) (PDF) (Word)

Nanotechnology: An Awareness Topic (HTM) (PDF) (Word)

Bibliography (HTM) (PDF) (Word)

Open Public Hearing

FDA's Initiative on Pharmaceutical Quality Systems for the 21st Century and the Debate on Delivered Dose Uniformity for Inhalers, Dr. Ajaz Hussain, MD (PDF)