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Thoratec Urgent Device Correction for HeartMate II

[ Price : $8.95]

Thoratec issues an Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II Left...

FDA Gives Breakthrough Status for Opdivo

[ Price : $8.95]

FDA grants Bristol-Myers Squibb a breakthrough therapy designation for Opdivo for treating advanced or metastatic renal cell carci...

Adverse Drug Reports Incomplete, Inaccurate: Tufts

[ Price : $8.95]

The Tufts Center for the Study of Drug Development says that many drug adverse event reports are incomplete or inaccurate, causing...

FDA Permanently Debars Huda

[ Price : $8.95]

Federal Register Notice: FDA issues an order permanently debarring Syed Huda from providing services to anyone with an approved or...

Bill to Speed Rare Disease Drugs

[ Price : $8.95]

Sens. Bennet, Burr, Warren, and Hatch introduce legislation to help speed development of targeted drugs for patients with serious ...

Mixed Reaction on Califf Nomination as FDA Head

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President Obamas nomination of Robert Califf as the next FDA commissioners receives mixed reactions from several groups, with some...

FDA Denies 3M Metered Dose Inhaler Petition

[ Price : $8.95]

FDA denies a 3M petition asking that albuterol sulfate actuators be embossed or labeled to indicate they are only to be used with ...

FDA Accepts Scilex NDA for Lidocaine Patch

[ Price : $8.95]

FDA accepts for review a Scilex Pharmaceuticals 505(b)(2) NDA for ZTlido (lidocaine patch 1.8%), indicated for treating postherpet...

New Zealands Jaychem Has CGMP Problems

[ Price : $8.95]

FDA warns New Zealands Jaychem Industries about CGMP violations and misbranding of some of its products.

CGMP Problems in Indias Pan Drugs

[ Price : $8.95]

FDA warns Pan Drugs about CGMP violations at its Vandodara, India, API manufacturing facility.