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Clinical Pharmacology

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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As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance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.

Documentation

Documentation Packaging Clinical Pharmacology Drug Development

The future of medical cannabis development in Europe

European Pharmaceutical Review

JULY 13, 2023

5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events. An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry.

Compounding

Compounding Drug Development Clinical Pharmacology Documentation

Pharmacist Digest

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

The future of medical cannabis development in Europe

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