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FDA proposes adverse-event reporting guidance for cellular, tissue products

AATB SmartBrief | Feb 25, 2015

The FDA has released new draft guidelines describing the kinds of adverse events related to the use of human cells, tissues and cellular and tissue-based products that should be reported to the FDA, and how establishments should report the events. The report should be filed by the establishment that makes HCT/Ps available for distribution, and it should be done within 15 days of discovering the event, the agency said. Regulatory Focus (02/19)


Cartilage allograft gives young athlete a chance to play again

AATB SmartBrief | Mar 18, 2015

FDA issues draft guidance for digital informed consent

AATB SmartBrief | Mar 11, 2015

Dental stem cells converted into corneal stromal cells

AATB SmartBrief | Mar 04, 2015

Cartilage produced from stem cells in preclinical study

AATB SmartBrief | Mar 11, 2015

Family tours lab where son's retinas were donated

AATB SmartBrief | Mar 25, 2015

FDA issues final rules on reusable medical devices

AATB SmartBrief | Mar 18, 2015

Study compares skin graft product with autologous grafts

AATB SmartBrief | Mar 11, 2015

Today is the last day to submit case studies for the 2015 QDSW!

AATB SmartBrief | Mar 18, 2015

Study describes development of leader cells in wound healing

AATB SmartBrief | Mar 18, 2015


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