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
As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.
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