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

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Biologics Consulting White Paper December 2017 2017 BIOLOGICS CONSULTING GROUP, INC. All Rights Reserved. 1 Regulatory Strategy for Pre-IND Meetings with FDA: Why Meet and What to Ask Authors Ronald A. Salerno, PhD Kerin Ablashi, MS Debra Barngrover, PhD, RAC Kelly Reich, MS, RAC Acknowledgements David Lin, PhD Christopher Bussineau, PhD Leslie Wolfe, PhD Benjamin Del Tito, PhD Biologics Consulting White Paper December 2017 2017 BIOLOGICS CONSULTING GROUP, INC. All Rights Reserved. 2 TABLE OF CONTENTS 1. INTRODUCTION ........................................ ........................................ ........................................ .. 4 Background ........................................ ........................................ ........................................ .................... 4 Purpose.

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.

  Phases, Drug, Regulatory, Studies, Strategy, Meeting, Idns, For phase 1 studies of drugs, Regulatory strategy for pre ind meetings