Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Tissue Framework Implementation Awaits Input From FDA Commissioner

This article was originally published in The Gray Sheet

Executive Summary

The Center for Biologics Evaluation & Research expects to brief FDA Commissioner Mark McClellan on the agency's three-part tissue framework in the next several weeks

You may also be interested in...



Tissue action plan

FDA delays effective date to Jan. 21, 2004 for registration and listing of establishments engaging in the processing of all human cells, tissues and cellular and tissue-based products (HCT/Ps) not currently regulated. In a Federal Register notice slated for publication Jan. 21, FDA cites "numerous comments submitted" to the agency, concluding "that implementing the registration final rule under the staggered effective date for remaining HCT/Ps would be contrary to the public interest." CBER recently explained that the agency first intended to publish a donor suitability final rule before concurrently implementing it with GTP final rules (1"The Gray Sheet" Oct. 21, 2002, p. 26). FDA will continue to accept voluntary registrations...

CBER Deputy Director Goodman To Assume Biologics Directorship In January

Incoming Center for Biologics Evaluation & Research Director Jesse Goodman, MD, brings a working relationship with blood test manufacturers from his experience as CBER deputy director

TSE Panel Comments On Tissue Decontamination Protocols, Pooled Samples

FDA should develop specific protocols for mitigating the transmission of Creutzfeld-Jakob disease and viral CJD in human cells, tissues and cellular and tissue-based products (HCT/Ps) for evaluation by the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) at a future meeting, TSEAC voted June 26
UsernamePublicRestriction

Register

MT017982

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel