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FDA Clears Alma Laser Skin Resurfacing Module

[ Price : $8.95]

FDA clears an Alma Lasers 510(k) for its PixelRF fractionated skin resurfacing module for cosmetic use with its Accent laser produ...

Mobile Medical App Policy Being Finalized

[ Price : $8.95]

CDRH official says the Center intends to finalize its draft guidance on mobile medical applications by the end of the year.

GSK Planning to Share More Data, Expertise

[ Price : $8.95]

GlaxoSmithKline says it is making internal data and clinical results available to researchers in an effort to promote transparency...

AngioDynamics Says Many Steps Respond to FDA Inspections

[ Price : $8.95]

AngioDynamics reports in an SEC filing steps it has taken many steps to respond to multiple FDA inspections at two of its faciliti...

Janssen Looking at Innovative Manufacturing Solution for Doxil

[ Price : $8.95]

Johnson & Johnsons Janssen drug unit explores an innovative collaboration with a new supplier to resolve an existing drug shortage...

NIH Workshop Wants Changes in Animal Study Design, Reporting

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A National Institute of Neurological Disorders and Stroke workshop recommends ways to improve animal study design and reporting.

Supreme Court Wont Hear OTC Case

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The Supreme Court declines to hear a case involving a state failure-to-warn suit for an OTC drug.

Markey to Introduce Compounding Pharmacy Bill

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Rep. Edward Markey says he will introduce legislation to strengthen FDA oversight of compounding pharmacies.

Still No FDA Determination on Amarin Vascepa Exclusivity

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Amarin says FDA cannot indicate when it will make a decision on the companys request that its Vascepa be declared a new chemical e...

Political Pressure Stopped Compounding Guidelines: Former FDAer

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Former FDA pharmacist Susan Sellers says that industry political pressure has kept the agency from publishing guidelines for more ...