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Get and Sign Chapter 48 Bioresearch Monitoring Human Drugs in Vivo Bioequivalence Compliance Program Form 2000-2022

Get and Sign Chapter 48 Bioresearch Monitoring Human Drugs in Vivo Bioequivalence Compliance Program Form 2000-2022

Use a Chapter 48 Bioresearch Monitoring Human Drugs In Vivo Bioequivalence Compliance Program Form 2000 template to make your document workflow more streamlined.

All exhibits covering clinical testing and analytical testing will be forwarded to the GLP and Bioequivalence Investigations Branch (GBIB), Division of Scientific Investigations (DSI), HFD-48, for final classification. When the clinical and analytical portions of a study have been performed at separate locations, separate reports should be prepared and submitted for each site. Completion of Attachment B is required for each study and for each study site subjected to inspection. Also complete...
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