Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.

FDA discusses a review perspective for early development IND submissions, with an emphasis on common missteps that can lead to clinical holds for CMC deficiencies and critical documentation for the original IND submission.
Presenters:
Paresma Patel, Ph.D., Acting Branch Chief, Division of New Drug API, CDER
Olen Stephens, Ph.D., Chemist, Division of New Products 1, Office of Pharmaceutical Quality, CDER
Learn more at: www.fda.gov/drugs/news-events...
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