CDER Quality Agreement Guidance Instructive For Supplement GMPs

This article was originally published in The Tan Sheet

12 Sep 2013
News

Dan Schiff d.schiff@elsevier.com

Executive Summary

Attorney Scott Bass expects a drug center guidance document on contract manufacturer quality agreements to “have a profound effect” on dietary supplement firms as well. Daniel Fabricant, FDA’s top supplement official, says the guidance has broad takeaways across regulated product areas.

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CDER Quality Agreement Guidance Instructive For Supplement GMPs

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