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Audentes Therapeutics Regenerative Medicine Designation

[ Price : $8.95]

FDA grants Audentes Therapeutics a regenerative medicine advanced therapy designation for AT132 and its use in treating X-linked m...

Guide on Quality Attributes for Chewable Tablets

[ Price : $8.95]

FDA posts a guidance on Quality Attribute Considerations for Chewable Tablets that provides the agencys current thinking on the cr...

Guide Microdose Radiopharm Diagnostic Drugs

[ Price : $8.95]

FDA posts a guidance on Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.

Comments Extended on Animal Drug Trial Design Notice

[ Price : $8.95]

Federal Register notice: FDA extends the comment period for a previous notice about study designs intended to generate data to sup...

Info Collection Extension for Samples and Protocols

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for Samples and Protocols.

Panel to Review Sequent Aneurysm Embolization Device

[ Price : $8.95]

Federal Register notice: FDA announces a 9/27 Neurological Devices Panel meeting to review a Sequent Medical PMA for the Woven End...

Merck Expanded Label for Keytruda Approved

[ Price : $8.95]

FDA approves a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line ...

bioMerieux Recalls Vitek 2 AST P631

[ Price : $8.95]

bioMerieux recalls its Vitek 2 AST P631 after customer reports indicate an increase in the rate of non-detected methicillin-resist...

Info Collection Extension on Dispute Resolution Guide

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry on Formal Disput...

Panel to Review Pediatric Drug Safety

[ Price : $8.95]

Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee to discuss pediatric-focused safety reviews.