October 1, 2003

Draft Guidance on Formal CGMP Dispute Resolution

Arnold & Porter Advisory

On September 5, 2003, FDA formally announced the availability of a Draft Guidance entitled "Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practices (CGMP)." 68 Fed. Reg. 52777. The Draft Guidance is part of FDA's "Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach" initiative, first announced just over a year ago. The agency has invited the public to comment on the draft by March 3, 2004

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