PDF-Draft Guidance Temp05/22/15 PDF document

Established Conditions Reportable CMC Changes for Approved Drug and Biologic ProductsGuidance for IndustryDRAFT GUIDANCEThis guidance document is being distributed

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Published on 2016-03-21

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Draft Guidance Temp05/22/15: Transcript

PDF-Draft Guidance Temp05/22/15 PDF document

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Draft Guidance Temp05/22/15: Transcript

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