Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
December 20, 2012
April 24, 2020
9528f5d8-c247-4fdc-8dc2-a32ec6d6afad
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