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Guidance on Delaying, Denying a Drug Inspection

07/15/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Circumstances that Constitute Delaying, De...

Panel to Discuss Counterfeit, Unapproved Drugs

07/15/2013

Federal Register Notice: FDA’s Risk Communications Advisory Committee will meet 8/16, from 9 a.m. to 5 p.m. at the FDA White...

Panel Meeting Canceled

07/15/2013

Federal Register Notice: FDA has canceled the 7/17 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee due to...

Info on Mammography Standards Sent to OMB

07/08/2013

Federal Register Notice: FDA’s proposed collection of information, “Mammography Quality Standards Act Requirements,&rd...

Guidance on Cellular and Gene Therapy Product Trials

07/08/2013

Federal Register Notice: FDA is making available a draft guidance entitled Guidance for Industry: Considerations for the Design of...

Comments Sought on Youth Tobacco Prevention

07/08/2013

Federal Register Notice: FDA seeks comments on Copy Testing of FDA’s General Market Youth Tobacco Prevention Campaigns. Copy...

Metadate ER Not Withdrawn for S&E

07/08/2013

Federal Register Notice: FDA has determined that Metadate ER (methylphenidate hydrochloride) extended-release tablet, 10 mg was no...

FDA Exempts Misconduct Proceedings from Privacy Act

07/08/2013

Federal Register Final rule: FDA is exempting a system of records from certain requirements of the Privacy Act to protect the inte...

FDA Corrects Reclassification of Wheelchairs

07/08/2013

Federal Register Proposed order: FDA is correcting typographical errors in the DATES section of a proposed order from the 6/12 Fed...

Comments Sought on Minor Use and Minor Species Act

07/08/2013

Federal Register Notice: FDA is seeking public comments on a proposed collection of information on the paperwork associated with d...