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FDA Clarifies Device Special Controls Guidance

03/28/2011

Federal Register Notice: FDA is making available updated special controls guidance documents for Class 2 devices, containing edits...

Comments Extended on NARMS Plan

03/25/2011

Federal Register Notice: FDA is extending the comment period for a 1/24 Federal Register notice, which sought comments on a docume...

Pediatric Anesthesia Safety Grant Funds Available

03/25/2011

Federal Register Notice: FDA is announcing the availability of grant funds for the support of the Pediatric Anesthesia Safety Init...

Info on Unapproved Animal Drugs Sent to OMB

02/25/2011

Federal Register Notice: FDA’s proposed collection of information, “Index of Legally Marketed Unapproved New Animal Dr...

OMB OKs Info on Charging for Investigational Drugs

02/25/2011

Federal Register Notice: The Office of Management and Budget has approved an FDA collection of information, “Charging for In...

Date Changed for Tobacco Panel Meeting

02/25/2011

Federal Register Notice: FDA is amending the notice of a meeting of the Tobacco Products Scientific Advisory Committee to reflect ...

Theophylline Solution Not Withdrawn for S&E

02/22/2011

Federal Register Notice: FDA has determined that theophylline oral solution, 80 mg/15 mL, was not withdrawn from sale for reasons ...

Guidance on Clinical Pharmacogenomics in Early Phase Studies

02/18/2011

Federal Register Notice: FDA is making available a draft guidance, Clinical Pharmacogenomics: Premarketing Evaluation in Early Pha...

Comments Extended on Unapproved Marketed Animal Drugs

02/18/2011

Federal Register Request for comments: FDA is extending to 4/19, the comment period for the 12/20/10 Federal Register notice seeki...

Decaspray and Aeroseb-Dex Not Withdrawn for S&E

02/09/2011

Federal Register Notice: FDA has determined that Decaspray (dexamethasone) topical aerosol, 0.04%, and Aeroseb-Dex (dexamethasone)...