Drugs

Current Good Manufacturing Practices (cGMP) for Drugs: Reports, Guidances and Additional Information

Second Progress Report and Implementation Plan, September 2003

Guidances

 cGMP Implementation

Task Group Progress Reports (February 2003)

Public Feedback

Public Workshop: "A Drug Quality System for the 21st Century,"  April 22-24, 2003, Washington, D.C.

  • Workshop Information, including Background, Final Agenda and Breakout Session Topics.  Cosponsored by the Product Quality Research Institute (PQRI) and the Food and Drug Administration (updated 4/16/2003)
  • Workshop Summary

FDA’s Pharmaceutical Quality Initiatives – Implementation of a Modern Risk-Based Approach, February 28 to March 2, 2007, Bethesda, Maryland

Other Reports and Announcements