10/07/2015
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel will meet 11/18 from 8 a.m. to 6 p.m. and 11/19, f...10/07/2015
Federal Register Notice: FDA is correcting a docket number in a notice entitled “Fee for Using a Rare Pediatric Disease Prio...10/06/2015
Federal Register Notice: FDA’s proposed collection of information, “Generic Drug User Fee Cover Sheet; Form FDA 3794 O...10/06/2015
Federal Register Notice: FDA is making available a guidance for industry entitled Acceptability of Draft Labeling to Support ANDA ...10/06/2015
Federal Register Notice: FDA is reopening the comment period until 1/4/16 for the Established Conditions: Reportable Chemistry, Ma...10/06/2015
Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Versi...10/06/2015
Federal Register Notice: FDA is announcing a pilot project for submitting final approved Risk Evaluation and Mitigation Strategies...10/06/2015
Federal Register Notice: FDA is publishing a list of PMAs that have been approved to inform the public of the availability of safe...