FDA Issues New Guidance Document

FDA issued a new Guidance for Industry on January 11, 2006. It is titled Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.

This guideline was prepared by FDA’s Dispute Resolution Working Group formed as part of the August 2002 FDA Initiative - Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach.

Download a copy of this new guidance document here. http://www.gmptrainingsystems.com/asp/resources.asp
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