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CDER Invites Participants for Sites Tours Programs

02/22/2012

Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Intera...

FDA Permanently Debars Marks

02/22/2012

Federal Register Notice: FDA is issuing an order under the FD&C Act permanently debarring Stephen L. Marks from providing services...

FDA Releases Final Product-Specific BE Recommendations

02/22/2012

Federal Register Notice: FDA is making available final product-specific bioequivalence (BE) recommendations that provide guidance ...

Workshop on Postmarket Sudy Design & Methodology

02/16/2012

Federal Register Notice: FDA is sponsoring a workshop 3/7 entitled, “Design and Methodology for Postmarket Surveillance Stud...

Info on Device Recall Authority Sent to OMB

02/10/2012

Federal Register Notice: FDA’s proposed collection of information, “Medical Device Recall Authority —21 CFR Part...

Guidance on Safety Data for Late Stage Trials

02/10/2012

Federal Register Notice: FDA is making available a draft guidance for industry, Determining the Extent of Safety Data Collection N...

Panel to Discuss Talon NDA for Leukemia

02/06/2012

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 3/21, from 8 a.m. to 12:45 p.m. at the FDA White...

Rule Finalized on Exceptions for National Stockpile

02/06/2012

Federal Register Final rule: FDA is adopting as a final rule, without change, the interim final rule that issued regulations permi...

Animal Drug Sponsor Changed to Quo Vademus

02/06/2012

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for an ANADA for chlortetr...

Info on Mfr. Marks on Single-Use Devices Sent to OMB

02/06/2012

Federal Register Notice: FDA’s proposed collection of information, “Prominent and Conspicuous Mark of Manufacturers on...