Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

July 20-21, 2004

Briefing Information

Introduction Memorandum (HTM) (PDF) (Word)

The Science of Quality By Design, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

ICH Quality Plenary Meeting (HTM) (PPT)

Draft ICH Concept Paper: Proposal for the Preparation of a Quality Guidline on Pharmaceutical Development (HTM) (PDF) (Word)

Concept Paper for the Establishment of an ICH Risk Management: Application to Quality Requirements and Practices Expert Working Group (EWG) (HTM) (PDF) (Word)

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

Process Analytical Technology and ASTM Committee E55 (HTM) (PDF) (Word)

Challenges and Opportunities in Enhancement of the CMC Section of NDAs: Quality - by- Design, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

On the Road to "Process Understanding", Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Risk-Based CMC Review, Dr. Moheb Nasr, PhD, FDA (HTM) (PPT)

Executive Summary - Critical Path (PDF)

Baysesian Approaches (HTM) (PDF) (Word)

Guidance for Industry" Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products, November 1995 (PDF)

Efficient Risk Based Regulatory Scrutiny for Assuring Pharmaceutical Quality in the 21st Century, Dr. Ajaz Hussain, PhD and David Horowitz, Esq., FDA (HTM) (PPT)

Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, August 2003 (PDF)

Guidance for Industry: Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing and Controls Information, September 2003 (PDF)

Quality by Design The Challenge for Regulators (HTM) (PPT)