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Guidance on No-Tobacco-Sale Order


Federal Register Notice: FDA is making available a guidance for tobacco retailers entitled Determination of the Period Covered by ...

FDA Submits Device Reporting Info to OMB


Federal Register Notice: FDA’s proposed collection of information “Medical Device Reporting: Manufacturer, Importer, U...

Workshop on IVD Testing for Anticoagulants


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

Comments Extended on Quality Metrics Guidance/Meeting


Federal Register Notice: FDA is extending the comment period until 11/27 for a 7/28 and 8/7 Federal Register notice of a draft gui...

Public Meeting on Farm Antimicrobial Drug Use, Resistance


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


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


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


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


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


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