Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018

  Рет қаралды 12,048

U.S. Food and Drug Administration

U.S. Food and Drug Administration

4 жыл бұрын

CDER’s Maureen Dillon-Parker and Judit Milstein discuss the content and format of an initial IND submission and what to expect during the first 30 days, including processes for clinical holds and best practices.
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