The End-of-Phase 2 FDA meeting is the optimum time to obtain FDA input at a single Type B meeting on the remaining pharmacology and toxicology studies, chemistry manufacturing and controls (CMC) of the clinical formulation, and the overall IND clinical plan to support an NDA submission for market approval. Therefore, it is essential to give proper forethought and attention to the all-important steps in preparing for the EOP-2 FDA meeting.
In this conference our speaker, veteran industry expert Dr. Larry Hofmann, gives expert guidance on the optimum background and makeup of your EOP-2 FDA meeting team. He also discusses strategic planning for and preparation of the FDA meeting information package, which must include available pharmacology and toxicology, Phase 1 and Phase 2 study summaries, as well as a summary of CMC data on the previous IND clinical formulations and proposed Phase 3 formulation to support the proposed Phase 3 and remaining Phase 1 study protocols.
FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan is being presented by Dr. Larry Hofmann, President, of LMH Associates, Inc. and airs on Tuesday, November 3, 2009. For more information, or to register for this event please visit our site at www.fxconferences.com
