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Drug User Fees Announced for FY ‘06

08/01/2005

Federal Register Notice: FDA is announcing the rates for prescription drug user fees for fiscal year (FY) 2006 adjusted for inflat...

FDA Set FY ’06 Animal Drug User Fees

08/01/2005

Federal Register Notice: FDA is announcing the rates and payment procedures for fiscal year (FY) 2006 animal drug user fees. The r...

Decision on Enrofloxacin in Poultry is Available

08/01/2005

Federal Register Notice: FDA is making available the final decision setting forth the findings of fact and conclusions of law on t...

FDA Withdraws Bayer’s NADA for Enrofloxacin

08/01/2005

Federal Register Final rule: FDA is amending the animal drug regulations by removing the portions reflecting approval of a new ani...

Animal Drug Sponsor Changes to Elanco

08/01/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for a new animal drug appl...

Thomas M. Rodgers Debarred

07/28/2005

Federal Register Notice: FDA is denying Thomas M. Rodgers, Jr.'s request for a hearing and is issuing an order under the Federal F...

Review Period Set for Zubrin

07/28/2005

Federal Register Notice: FDA has determined the regulatory review period for Johnson & Johnson’s Zubrin (tepoxalin) is 1,887 days ...

Info on Pharmaceutical CGMPs Sent to OMB

07/25/2005

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice Regulations for Finished P...

Guidance on Safe Starting Dose in Initial Trials

07/22/2005

Federal Register Notice: FDA is making available a guidance for industry entitled Estimating the Maximum Safe Starting Dose in Ini...

Panel to Discuss Multiple-Use Nozzle Jet Injectors

07/22/2005

Federal Register Notice: FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee will meet...