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Guidance on Therapeutic Cancer Vaccines

09/18/2009

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Clinical Considerations for Ther...

ICH Prep Meeting Slated

09/18/2009

Federal Register Notice: FDA will hold a public meeting 10/14 entitled “Preparation for ICH meetings in St. Louis, Missouri&...

Public Workshop on Blood Establishment Software

08/28/2009

Federal Register Notice: FDA will hold a public workshop 11/4-5 entitled “Blood Establishment Computer Software: Understandi...

Workshop on Post-Approval Device Studies

08/19/2009

Federal Register Notice: FDA will hold a public workshop 9/9-10 entitled, “Methodologies for Post-Approval Studies of Medica...

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Demadex Injection Not Withdrawn for S&E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...