FDA Seeks Comments on Manipulation of HCT/Ps

The U.S. Food and Drug Administration (FDA) is seeking comments from manufacturers of human cell, tissue- and cellular-based products as well as physicians who work with these materials in relation to its new draft guidance document, “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance,” which contains non-binding recommendations on regulations surrounding the use and manipulation of biological materials. The draft guidance was posted on December 23, 2014.

Physicians who would like to comment can submit one set of either electronic or written comments by the date provided in the December 23, 2014, Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to www.regulations.gov. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. They ask that all comments be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

The full draft guidance can be viewed online at www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulator....

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