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Panel Mulls Prestwick NDA for Chorea in Huntington’s

10/18/2007

Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 12/6, from 8 a.m. to...

Science Board Meeting Date Changed

10/18/2007

Federal Register Notice: FDA is amending a 10/2 notice of meeting of the Science Board to the Food and Drug Administration. The me...

Sole Drug Manufacturers Must Notify Before Discontinuing

10/18/2007

Federal Register Final rule: FDA is amending its regulations describing postmarketing reporting requirements to require an applica...

FDA Proposes Change on Live Vaccine Processing Regs

10/18/2007

Federal Register Proposed rule and direct final rule: FDA is proposing to amend the biologics regulations by providing options to ...

OMB OKs Special Protocol Assessment Info

10/18/2007

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Special Protocol Assessmen...

CDER Seeks Firms for Site Tour Program

10/17/2007

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

Device User Fees for FY ‘08

10/12/2007

Federal Register Notice: FDA is publishing the fee rates and payment procedures for medical device user fees for fiscal year 2008....

PDUFA Fees for FY ’08 Published

10/12/2007

Federal Register Notice: FDA is announcing the rates for prescription drug user fees for FY 2008. The rates for application fees f...

Public Workshop on Cell/Scaffold Products

10/12/2007

Federal Register Notice: FDA, CBER, CDRH, and the National Institute of Standards and Technology are announcing a public workshop ...

Error Corrected in Electrocardiograph Electrodes Guidance

10/12/2007

Federal Register Notice: FDA is correcting a docket number in a notice that appeared in the 10/4 Federal Register on the availabil...