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FDA Withdraws Guidance on Conjugated Estrogens

08/12/2005

Federal Register Notice: FDA is withdrawing a draft guidance for industry entitled Conjugated Estrogens, USP-LC-MS Method for Both...

Guidance Out on Quality Risk Management

08/08/2005

Federal Register Notice: FDA is making available a draft guidance entitled Q9 Quality Risk Management prepared under the auspices ...

OMB OKs Info on Electronic Records, Signatures

08/08/2005

Federal Register Notice: FDA’s collection of information entitled “Electronic Records; Electronic Signatures” has been approved by...

OMB Approves Info on Dietary Ingredient Premarket Notification

08/08/2005

Federal Register Notice: FDA’s collection of information entitled “Premarket Notification for a New Dietary Ingredient” has been a...

Comments Sought On Importer’s Entry Notice

08/03/2005

Federal Register Notice: FDA is seeking public comments on information collection provisions for the Importer’s Entry Notice. The ...

Anthrax Emergency Use Authorization Extended

08/03/2005

Federal Register Notice: On the request of the Department of Defense (DoD) FDA is extending the Emergency Use Authorization (for A...

Correction Made on Exemption Notice

08/03/2005

Federal Register Notice: FDA is correcting an incorrect title and docket number in a 7/26 Federal Register notice that announced O...

FDA Seeks Comments on ‘Approaches to Illness’ Workshop

08/03/2005

Federal Register Notice: As part of its Critical Path Initiative FDA is planning a two-day workshop to explore approaches and pote...

Mammography Panel to Meet

08/03/2005

Federal Register Notice: FDA’s National Mammography Quality Assurance Advisory Committee will meet 9/26-27, 2005, from 9 a.m. to 6...

Device Fee Rates for FY ’06 Delayed

08/01/2005

Federal Register Notice: FDA is delaying publication of the fee rates and payment procedures for medical device user fees for fisc...