Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

2023年3月20日 · Cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, …

Some examples of cell therapy products include stem cells and stem cell derived products, such as those from hematopoietic, mesenchymal, embryonic, and umbilical cord blood, cancer …

2023年3月10日 · In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials. Advanced Topics: …

For the purposes of this guidance, “cellular therapy products” include tissue-engineered medical products regulated under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262).

2024年11月18日 · Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food …

For additional information regarding PT for CGT products, refer to FDA’s guidance “Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry,” …

FDA approves Tecelra, a gene therapy to treat adults with unresectable or metastatic synovial sarcoma. Tecelra is also the first FDA-approved T cell receptor (TCR) gene therapy.

The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older.

2023年12月28日 · This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy …