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CRE's Regulatory Action
of the Week

FDA Reschedules Public Hearings on Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
The U.S. Food and Drug Administration has rescheduled a 2-day public hearing to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps).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 public hearing will be held on September 12 and 13, 2016, from 9 a.m. to 5 p.m. The hearing on September 13 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. Persons (including FDA employees) seeking to attend in person or to attend and speak at the public hearing must register by June 1, 2016.

  • Click here to read the Federal Register notice of this action, which provides more details.

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