federal_register: 2024-26918
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-26918 | Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The draft guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. | 2024-11-19 | 2024 | 11 | https://www.federalregister.gov/documents/2024/11/19/2024-26918/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products-draft-guidance | https://www.govinfo.gov/content/pkg/FR-2024-11-19/pdf/2024-26918.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The draft guidance document provides industry with... |