Regulatory Strategy for Pre-IND Meetings with FDA: Why ...

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs or 21 CFR 314.312.) PDUFA Prescription Drug User Fee Act Pre-IND Pre-Investigational New Drug Application RPM Regulatory Project Manager (at the FDA) Sponsor Sponsor means a person who takes responsibility for and initiates a clinical investigation.

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