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Hearing on HCT/P Draft Guidances

04/22/2016

Federal Register Notice: FDA will hold a two-day public hearing 9/12-13 to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The draft guidances are: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception, Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations, and Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products. he hearing will be held from 9 a.m. to 5 p.m. on both days, but the 9/13 hearing on may be extended or end early depending on the number of speakers scheduled. Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. The hearing will be held at the National Institutes of Health, 9000 Rockville Pike, Bldg. 10, Masur Auditorium, Bethesda, MD. Contact Lori Jo Churchyard, (240) 402-7911, lori.olsenchurchyard@fda,hhs.gov. To view this notice, click here.

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