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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

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

Putting Patients First Blog

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials (PDF) September 26, 2024 The Honorable Robert M. Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 RE: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. 8 Scott, P.,