What's New?

This is where we'll announce the most recent additions to our web site, as well as news from the FDA and the GMP Institute. If you've visited us before and want to know what's changed, take a look here first. 

FDA withdraws the direct final rule of 17 January 2006, amending CGMP regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the requirements in FDA's regulations. [HTML] [PDF] (2 May 2006)

Active Pharmaceutical Ingredient (API) Process Inspection; Compliance Program Guidance Manual (13 January 2006)

PET Drug Products - Current Good Manufacturing Practice (CGMP) [Word] or [PDF] (15 September 2005)

FEDERAL REGISTER:   Agency Information Collection Activities: Proposed Collection; Comment Request; Food and Drug Administration Survey of Current Manufacturing Practices in the Food Industry [HTML] [PDF] (14 September 2005)

Final Report on Pharmaceutical Manufacturing Initiative Issued  

Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs