FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.
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