FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs
PharmaTech
DECEMBER 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
Clinical Pharmacology Documentation Drug Development 
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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As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance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.
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