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OGD Wants Lidoderm Bioquivalence Study

[ Price : $8.95]

Endo disagrees with Office of Generic Drug recommendations for the kinds of studies needed to demonstrate bioequivalence to its Li...

Crawford Blatantly Violated Financial Principles: Fed

[ Price : $8.95]

The District of Columbia U.S. Attorney calls former commissioner Lester Crawfords financial disclosure and conflict of interest vi...

Device Complaints Least Important Quality Indicator?

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CDRH medical device quality systems expert Kimberly Trautman tells RAPS that complaints received by manufacturers may not be the b...

Guidance on Antiretrovirals for HIV

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Federal Register Notice: FDA releases a guidance on fixed dose combinations, co-packaged drug products, and single-entity versions...

Pediatric Studies Out for 5 Products

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Federal Register Notice: FDA posts summaries of pediatric studies for Altace, Gemzar, Lescol, Sandostatin LAR, and Serevent.

FDA Alliance Hires Patton Boggs as Lobbyist

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The FDA Alliance hire Washington attorneys Stuart Pape and Ed Newberry (Patton Boggs) as its lobbyists to pursue high congressiona...

Guidance Out on Bio Product Deviation Reporting

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CBER finalizes a guidance with its thinking on reporting biological product deviations.

Drug Distributor Guilty Plea in Counterfeit Case

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Albers Medical Distributors owner Douglas Albers enters a guilty plea for his role in selling counterfeit and misbranded Neupogen ...

Dispute Resolution Panel to Hear Acorn Appeal

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CDRHs Medical Device Dispute Resolution Panel will consider whether an additional clinical trial is needed for Acorn Cardiovascula...

Risk Fears Led to Natrecor De-adoption

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Research shows many physicians stopped prescribing Natrecor after publication of articles questioning its safety.