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Comments Extended on PDUFA Reauthorization Meeting

11/10/2010

Federal Register Notice: FDA is reopening until 10/31/11 the comment period for the notice of public meeting that published in the...

FDA Classifies Tissue Adhesive into Class 2

11/10/2010

Federal Register Final rule: FDA is classifying the tissue adhesive with adjunct wound closure device intended for topical approxi...

FDA Science Board Nominees Sought

10/20/2010

Federal Register Notice: FDA is requesting nominations for voting members from academia and industry to serve on the Science Board...

FDA OKs Pharmacia & Upjohn sNADA for Dairy Cows

10/14/2010

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pharmacia & Upjohn supplemental ...

Guidance on Determining if a Study Requires an IND

10/14/2010

Federal Register Notice: FDA is making available a draft guidance, Investigational New Drug Applications (INDs) — Determinin...

Guidance on INDs with Live Biotherapeutic Products

10/14/2010

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Early Clinical Trials with Live Biothera...

FDA OKs Boehringer NADA for Diabetic Cats

12/14/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Boehringer Ingelheim Vetmedica o...

Animal Drug Regs Change Sponsor to Intervet

12/14/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor's name from Schering- Plou...

Animal Drug Sponsor Changed to Huvepharma

11/23/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 10 new animal drug app...

FDA OKs Pharmacia & Upjohn sNADA for Heifers

11/23/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pharmacia & Upjohn Co. supplemen...