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FDA Regs Reflect March NADA, ANADA Approvals

04/15/2014

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during M...

Zovirax Not Withdrawn for S&E

04/11/2014

Federal Register Notice: FDA has determined that Zovirax (acyclovir sodium) injection, equivalent to 250 mg base/vial, 500 mg base...

Panel to Discuss OTC Singulair Allergy

04/11/2014

FDA Changes Advisory Committee Name/Function

04/11/2014

Federal Register Final rule: FDA is amending the standing advisory committees’ regulations to change the name and function o...

FDA Posts Health IT Report

04/07/2014

Comments Sought on Animal Feed Records

04/07/2014

Comments Sought on Antibacterial/Antimicrobial Guidance

04/07/2014

Federal Register Notice: FDA is seeking comments on its Guidance for Industry on Updating Labeling for Susceptibility Test Informa...

Skelaxin Not Withdrawn for S&E

04/07/2014

Federal Register Notice: FDA has determined that Skelaxin (metaxalone) tablets, 400 mg was not withdrawn from sale for reasons of ...

Review Period Set for Mela Sciences’ Melafind System

04/07/2014

Federal Register Notice: FDA has determined the regulatory review period for MELA Sciences Inc.’s Melafind System is 3,837 d...

Comments Sought on Type A Medicated Article Records

04/07/2014