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FDA Corrects Rule on ANDAs, 505(b)(2)s

03/13/2015

Federal Register Correction: FDA is making several corrections to a 2/6/15 proposed rule, pages 6801-6896, that proposed regulatio...

FDA Posts NADA, ANADA Approvals

03/13/2015

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

FDA Submits Info on 513(g) Requests to OMB

03/09/2015

Federal Register Notice: FDA’s proposed collection of information, “513(g) Request for Information,” has been su...

Docket Established on Human Drug Compounding

03/09/2015

Federal Register Notice: FDA is establishing a public docket, Docket No. [FDA-2015-N-0030], to receive information, recommendation...

Revised Guidance on Veterinary Drug Metabolism/Residue Kinetics

03/09/2015

Federal Register Notice: FDA is making available a revised guidance for industry entitled Studies to Evaluate the Metabolism and R...

Guidance on Veterinary Drug Residue Depletion Studies

03/09/2015

Federal Register Notice: FDA is making available a revised guidance for industry entitled Studies to Evaluate the Metabolism and R...

FDA Posts Bioequivalence Recommendations

03/09/2015

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...

Workshop on Companion Diagnostics for Targeted Therapies

03/09/2015

Federal Register Notice: FDA will co-sponsor with the American Association for Cancer Research and the American Society of Clinica...

Info on Animal Food/Feed Sent to OMB

03/09/2015

Federal Register Notice: FDA’s proposed collection of information, “Substances Prohibited From Use in Animal Food or F...

Comments Sought on ID Testing of Dietary Ingredients

03/09/2015

Federal Register Notice: FDA is seeking comments on the information collection provisions of its existing regulations governing pe...