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Advancements in IND Process – Insights from Dr. David A. Lepay at the FDA

On December 10, 2001, Dr. David A. Lepay, Senior Advisor for Clinical Science at the FDA, presented valuable insights into the Investigational New Drug (IND) process at a Johns Hopkins program. His discussion highlighted the regulatory considerations, best practices, and evolving landscape of drug development. Dr. Lepay emphasized the importance of collaboration between sponsors and regulatory bodies to ensure patient safety and efficacy in clinical trials, reflecting on the impact of these processes on medical advancements.

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Advancements in IND Process – Insights from Dr. David A. Lepay at the FDA

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    1. The IND Process David A. Lepay, M.D., Ph.D. Senior Advisor for Clinical Science Office of the Commissioner, US FDA Johns Hopkins Program December 10, 2001

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