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Workshop on IVD Testing for Anticoagulants

08/26/2015

Federal Register Notice: FDA will hold a public workshop 10/26 entitled “In Vitro Diagnostic Testing for Direct Oral Anticoa...

Public Meeting on Farm Antimicrobial Drug Use, Resistance

08/20/2015

Federal Register Notice: FDA, the U.S. Department of Agriculture and the Centers for Disease Control and Prevention will hold a pu...

FDA Permanently Debars Coroniti

08/20/2015

Federal Register Notice: FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Lisa Coronit...

FDA Establishes Docket for Inactive Ingredient Database

08/20/2015

Federal Register Notice: FDA is establishing a public docket to receive comments from interested parties on enhancing the utility ...

FDA Corrects Notice on Pediatric Safety Reviews

08/20/2015

Federal Register Notice: FDA is correcting an 8/12 Federal Register notice on the Pediatric Advisory Committee meeting scheduled t...

Panel to Discuss NDA for Hypogonadism

08/20/2015

Federal Register Notice: FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee will meet 11/3, from 8:30 a.m. to 5...

FDA Adds 2 Tropical Diseases for Possible Priority Review

08/20/2015

Federal Register Final order: The FD&C Act authorizes FDA to award priority review vouchers (PRVs) to tropical disease product app...

Guidance on Tests/Labeling for Intravascular Stents

08/18/2015

Federal Register Notice: FDA is making available a guidance: Select Updates for Non-Clinical Engineering Tests and Recommended Lab...

Guidance on Drugs for Treating Gonorrhea

08/18/2015

Federal Register Notice: FDA is making available a guidance for industry: Uncomplicated Gonorrhea: Developing Drugs for Treatment....

Guidance on E-Submissions of Vaccine Safety Reports

08/18/2015

Federal Register Notice: FDA is making available a document entitled Providing Submissions in Electronic Format — Postmarket...