Food and Drugs Administration
May 21-22, 2003 Briefing Information
Cover Letter, Helen Winkle (PDF)
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, FDA (PDF)
Summary Progress Report Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, FDA (PDF)
Sterile Drug Products Produced by Aseptic Processing (Draft), FDA (PDF)