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Panel Meets on BioMarin NDA for Duchenne Muscular Dystrophy

10/15/2015

Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/24, from 8 a.m. t...

Comments Reopened on PDUFA Reauthorization

10/14/2015

Federal Register Notice: FDA is reopening until 4/29/16 the comment period for the notice of public meeting that appeared in the 5...

Guidance on Animal Studies for Medical Devices

10/14/2015

Federal Register Notice: FDA is making available a draft guidance entitled General Considerations for Animal Studies for Medical D...

Guidance on Microbial Vectors Used for Gene Therapy

10/14/2015

Federal Register Notice: FDA is making available a draft document entitled Recommendations for Microbial Vectors Used for Gene The...

FDA Corrects Notice on Pediatric Disease Vouchers

10/07/2015

Federal Register Notice: FDA is correcting a docket number in a notice entitled “Fee for Using a Rare Pediatric Disease Prio...

Panel to Discuss Hemorrhoid Classification Codes, Heart Care System

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...

Guide on Electronic Common Technical Document

10/06/2015

Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Versi...

Pilot Project for Drug REMS in SPL Format

10/06/2015

Federal Register Notice: FDA is announcing a pilot project for submitting final approved Risk Evaluation and Mitigation Strategies...

FDA Posts List of Approved PMAs

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...

Info on Generic Drug User Fees Sent to OMB

10/06/2015

Federal Register Notice: FDA’s proposed collection of information, “Generic Drug User Fee Cover Sheet; Form FDA 3794 O...