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Intersect ENT sPMA for Propel Sinus Implant

[ Price : $8.95]

Intersect ENT files a PMA supplement seeking approval to expand the indication of the Propel mini steroid releasing sinus implant ...

Rare Disease Clinical Trials Bill Heads to Obamas Desk

[ Price : $8.95]

The Ensuring Access to Clinical Trials Act of 2015 moves to president Obamas desk for signing after the House passed the measure 9...

Ortho Evra Transdermal System Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Ortho Evra Transdermal System was not withdrawn from sale for reasons of safety or ef...

Panel to Discuss Telesta NDA for Bladder Cancer

[ Price : $8.95]

Federal Register Notice: FDAs Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee w...

FDA Priority Review for Halaven sNDA

[ Price : $8.95]

FDA accepts for priority review an Eisai supplemental NDA for Halaven (eribulin mesylate) and its use in treating patients with in...

Safety Alert on Proper Cranial Perforator Use

[ Price : $8.95]

FDA issues a safety alert to remind neurosurgeons about the techniques for the safe use of cranial perforators with an automatic c...

FDA Rejects Cephalon Petition on Treanda ANDAs

[ Price : $8.95]

FDA declines without comment a Cephalon petition that urged the agency to not approve an ANDA that references its Treanda (bendamu...

Ex-Novartis R&D Specialist to Lead CDER Quality Office

[ Price : $8.95]

FDA chooses former Novartis global research and development vice president Michael Kopcha as CDER Office of Pharmaceutical Quality...

ICH Revision to Good Clinical Practice Guideline

[ Price : $8.95]

FDA posts an International Conference on Harmonization draft guideline that revises E6 (R1): Guideline For Good Clinical Practice ...

FDA Sets Fee Rate for Rare Pediatric Disease Vouchers

[ Price : $8.95]

Federal Register Notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 201...