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Guidance on Drug-Induced Liver Injury

10/25/2007

Federal Register Notice: FDA is making available draft guidance for industry, Drug-Induced Liver Injury: Premarketing Clinical Eva...

Guidance on In Vitro Diagnostic Device Studies

10/25/2007

Federal Register Notice: FDA is making available a draft guidance, Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic ...

Guidance on Product-Specific BE Recommendations

10/25/2007

Federal Register Notice: FDA is making available items that were omitted and correcting a 5/31 draft guidance on bioequivalence (B...

DTC User Fee Program Detailed

10/25/2007

Federal Register Notice: FDA is explaining the new direct-to-consumer (DTC) user fee program and asking companies to notify the ag...

Info on Blood CGMPs OK’d by OMB

10/25/2007

Federal Register Notice: FDA’s collection of information, “CGMP for Blood and Blood Components; Notification of Consig...

Workshop on Pandemic Vaccine Development

10/25/2007

Federal Register Notice: FDA is holding a public workshop, “Immune Correlates of Protection against Influenza A Viruses in S...

FDA OKs Elanco Animal Health Drug for Dog Fleas

10/25/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Elanco Animal Health NADA that ...

Info on DTC Ad Brief Summaries Approved by OMB

10/22/2007

Federal Register Notice: FDA’s collection of information, “Experimental Evaluation of Variations in Content and Format...

Comments Extended on Electronic Package Insert

10/22/2007

Federal Register Notice: FDA is reopening to 12/6 the comment period for the 4/2 Federal Register notice related to a 4/27 public ...

Panel to Discuss Astellas Pharma and Solvay NDAs

10/18/2007

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 12/11-12, from 8 a.m. to 5 p.m. a...