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Nubain Not Withdrawn for S&E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Federal Register Notice: FDA has determined that Nubain (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, was not withdrawn f...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Federal Register Notice: FDA is making available a draft guidance, Tropical Disease Priority Review Vouchers.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...

FDA Seeks Helps Identifying BPA Products

10/15/2008

Federal Register Notice: FDA is requesting assistance in identifying types of FDA-regulated products that contain Bisphenol A (BPA...

Nominations Sought for Device Panels

10/15/2008

Federal Register Notice: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advis...

Panel to Discuss 2 NDAs for Skin Infections

10/15/2008

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 11/18, from 8 a.m. to 5 p.m., 11/19 from 8 ...

Panel to Discuss Takeda’s Uloric

10/15/2008

Federal Register Notice: FDA’s Arthritis Advisory Committee will meet 11/24, from 8:30 a.m. to 4:30 p.m. at the Hilton Washi...