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FDA issues draft guidance clarifying exemptions for cell, tissue procedures

AATB SmartBrief | Oct 29, 2014

The FDA has issued a draft guidance that specifies when surgeries involving human cell, tissue or cellular or tissue-based products qualify as exempt from regulation. The FDA exempts procedures that implant the products into the same individual from which they were removed during the same surgical procedure and avoid intervening processing beyond rinsing, cleansing or certain manufacturing processes. Surgeries that take place at two different sites would not qualify for exemption. The FDA will accept comments on the guidance until Dec. 22. Regulatory Focus (10/24)


Near-total face transplant performed at Cleveland Clinic

AATB SmartBrief | Nov 19, 2014

CDC releases Ebola monitoring guidelines

AATB SmartBrief | Oct 29, 2014

Brigham and Women's surgeons perform bilateral arm transplant

AATB SmartBrief | Nov 26, 2014

Human tendons produced in the laboratory

AATB SmartBrief | Nov 12, 2014

Quarterback's experience shows allografts becoming more common in sports medicine

AATB SmartBrief | Nov 26, 2014

AATB Ebola Screening Guidance

AATB SmartBrief | Oct 29, 2014

CDC warns of chikungunya risk among travelers

AATB SmartBrief | Nov 12, 2014

Pentagon supports research into whole-eye transplants

AATB SmartBrief | Nov 05, 2014

Researchers find evidence of Chagas disease spreading in U.S.

AATB SmartBrief | Nov 05, 2014


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AATB SmartBrief | Nov 26, 2014

2015 Uniform DRAI Workshop

AATB SmartBrief | Nov 26, 2014

AATB 2014 November Webinar

AATB SmartBrief | Nov 19, 2014

The 2015 DRAI Workshop will be Feb. 3-4 at the Westin Tampa Harbour Island in Tampa, Fla.

AATB SmartBrief | Nov 12, 2014

AATB November webinar

AATB SmartBrief | Nov 12, 2014




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