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FDA has issued a frequently asked questions (FAQ) document on using FDA’s Form 3911 for notifying the agency about illegitimate or suspected products as required by the Drug Supply Chain Security Act (DSCSA). [For an extended analysis of the wide-range of issues and challenges that industry and the agency are facing in implementing DSCSA, see IPQ’s April/May 2016 and January 2016 Monthly Updates.]
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
