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FDA issues draft guidance clarifying exemptions for cell, tissue procedures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The FDA has issued a draft guidance that specifies when surgeries involving human cell, tissue or cellular or tissue-based products qualify as exempt from regulation.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)


CDC releases Ebola monitoring guidelines

AATB SmartBrief | Oct 29, 2014

Woman with transplanted uterus gives birth

AATB SmartBrief | Oct 08, 2014

Ohio introduces mobile tablets to ease donor registration

AATB SmartBrief | Oct 22, 2014

AATB Ebola Screening Guidance

AATB SmartBrief | Oct 29, 2014

CDC issues new Ebola guidelines for health care workers

AATB SmartBrief | Oct 22, 2014

Stem cell therapy improves sight of patients with macular degeneration

AATB SmartBrief | Oct 15, 2014

2nd hospital worker in Texas tests positive for Ebola

AATB SmartBrief | Oct 15, 2014

Globus Medical buys Texas bone allograft maker

AATB SmartBrief | Oct 29, 2014

Human eyes have reservoir of stem cells, study says

AATB SmartBrief | Oct 08, 2014


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AATB Ebola Screening Guidance

AATB SmartBrief | Oct 29, 2014

Upcoming AATB webinars

AATB SmartBrief | Oct 29, 2014

AATB Ebola screening guidance

AATB SmartBrief | Oct 22, 2014

AATB October webinar

AATB SmartBrief | Oct 22, 2014

Call for proposals

AATB SmartBrief | Oct 15, 2014




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