• A Brief Guide to Understanding: FDA's CMC Guidance for Phase 2 and 3 INDs

  • Sep 13 2023
  • Length: 9 mins
  • Podcast

A Brief Guide to Understanding: FDA's CMC Guidance for Phase 2 and 3 INDs

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  • Summary

  • This audiocast discusses navigating CMC guidance, meeting regulatory requirements, drug substance/product information, FDA expectations, and quality requirements for progressing from Phase 2 to Phase 3.
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