Wednesday, May 29, 2013

FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

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