Expedited IND Rolling Submission Process and Program Structure - TheNote.app

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Expedited IND Rolling Submission Process and Program Structure

A majority of the Expedited IND Pilot will take place during the “Pre-IND” phase – the period of nonclinical development before the sponsor submits their official 30-day IND application.

http://www.fda.gov/industry/fda-expedited-investigational-new-drug-ind-pilot-program/expedited-ind-rolling-submission-process-and-program-structure fda.gov

RSS Hunter • Sep 15