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Info on Med Guide Requirements Sent to OMB

11/26/2008

Federal Register Notice: FDA’s proposed collection of information, Prescription Drug Product Labeling: Medication Guide Requ...

Comments Sought on TV Drug Ad Toll-Free Numbers

11/26/2008

Federal Register Notice: FDA is seeking comments on a study examining the impact on consumer comprehension of inclusion of a toll-...

Workshop on Sex Differences in Cardio Device Trials

11/26/2008

Federal Register Notice: FDA and AdvaMed are co-sponsoring a public workshop 12/9, “Sex Differences in the Cardiovascular De...

Panel to Discuss Erbitux and Vectibix Oncology Drugs

11/21/2008

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 12/16, from 8 a.m. to 4 p.m. at the Hilton Washi...

Nubain Not Withdrawn for S&E

11/21/2008

Federal Register Notice: FDA has determined that Nubain (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, was not withdrawn f...

Comments Sought on Single-Use Device Labeling

11/17/2008

Federal Register Notice: FDA seeks comments on reprocessed single-use device labeling, “Compliance With Section 301 of the M...

Somatuline Depot Review Period Set

11/17/2008

Federal Register Notice: FDA has determined the regulatory review period for Somatuline Depot is 3,629 days for extending a patent...

Guidance on Tropical Disease Priority Review

10/20/2008

Federal Register Notice: FDA is making available a draft guidance, Tropical Disease Priority Review Vouchers. It explains to stake...

OMB OKs Marketing Permit Info Collection

10/17/2008

Federal Register Notice: FDA’s collection of information, “Temporary Marketing Permit Applications,” has been ap...

Panel to Vote on NaviStar Catheter

10/15/2008

Federal Register Notice: FDA’s Circulatory System Devices Panel will meet 11/20, from 8 a.m. to 5:30 p.m. at the Gaithersbur...