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Panel to Discuss Merck’s Gardasil and Glaxo Vaccine

08/17/2009

Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 9/9 from 8 a.m. to abou...

Demadex Injection Not Withdrawn for S&E

08/17/2009

Federal Register Notice: FDA has determined that Demadex (torsemide) injection, 20 mg/2 mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), w...

Guidance on Avoiding Risk of Melamine Contamination

08/07/2009

Federal Register Notice: FDA is making available a guidance for industry, Pharmaceutical Components at Risk for Melamine Contamina...

Info on Request for Bio Samples and Protocols Sent to OMB

07/29/2009

Federal Register Notice: FDA’s proposed collection of information, “Request for Samples and Protocols,” has been...

Review Period Set for Senju Pharma’s Durezol

07/29/2009

Federal Register Notice: FDA has determined the regulatory review period for Senju Pharmaceutical’s Durezol is 560 days for ...

Review Period Set for Kissei Pharma’s Rapaflo

07/29/2009

Federal Register Notice: FDA has determined the regulatory review period for Kissei Pharmaceutical’s Rapaflo is 3,681 days f...

Animal Drug Sponsor Changed to Cross Vetpharm

07/22/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for three NADAs and one ab...

FDA Withdraws 2 NADAs, 1 ANADA

07/22/2009

Federal Register Notice and Final rule: FDA is withdrawing approval of two NADAs (Wellmark International’s Zodiac Fleatrol F...

OMB OKs Info on Clinical Trial Data Monitoring

07/22/2009

Federal Register Notice: FDA’s collection of information, “Guidance for Clinical Trial Sponsors: Establishment and Ope...

OMB OKs Info on Notice of Participation

07/22/2009

Federal Register Notice: FDA’s collection of information entitled “Notice of Participation” has been approved by...