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Pondimin, Ponderex Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Pondimin and Ponderex were withdrawn from sale for reasons of safety or effectiveness...

Medsource Inspection Finds QS Violations

[ Price : $8.95]

FDAs New England District Office warns Medsource about Quality System regulation and other violations.

FDA Proposing New Intended Use Definition

[ Price : $8.95]

An Inside Medical Devices analysis says drug and medical device companies should consider and comment on a proposed regulation rev...

Industry Needs More Time for Analytical Control Strategies: GPhA

[ Price : $8.95]

The Generic Pharmaceutical Association says a significant investment of time and resources is required to establish an analytical ...

FDAs Amarin Problems Traced to Caronia Decision

[ Price : $8.95]

Skadden attorneys say that FDAs failure to appeal its off-label promotion case in United States v. Caronia led to a federal judges...

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Ortho Evra Transdermal System Not Withdrawn for S&E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Federal Register Notice: FDA determines that Ortho Evra Transdermal System was not withdrawn from sale for reasons of safety or ef...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