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Regulatory Update

Posted 01 January 2009

Draft Guidance for Industry on Process Validation: General Principles and Practices (Docket No. FDA-2008-D-0559). Comments on this draft guidance are due by 21 January 2009; they can be submitted electronically at or on paper to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.


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