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New Medical Device Tax Will Cut Workforce: Survey

[ Price : $8.95]

AdvaMed members surveyed say the medical device tax taking effect 1/1/13 will lead to layoffs or reduced hiring.

2 New Site Data Submission Guidances

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FDA issues guidances to help NDA and BLA sponsors submit summary level clinical site datasets in a standardized electronic format.

Amgen to Pay $762 Million to Settle Aranesp Marketing Suit

[ Price : $8.95]

Amgen says it is waiting for judicial approval of its agreement to pay $762 million to resolve civil and criminal charges that it ...

Glaxo, Theravance NDA for COPD Drug

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GlaxoSmithKline and Theravance file an NDA for their investigational once-daily LAMA/LABA combination medicine for patients with c...

5 LASIK Doctors Warned About Advertising

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FDA warns five eye care providers about LASIK advertising that doesnt give consumers sufficient risk information.

Report Finds Obstacles to Biosimilar Pathway Adoption

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A new Congressional Research Service report on FDAs biosimilars pathway finds that navigating the approval path will be an arduous...

FDA Fast Track for IBS Drug

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FDA grants fast track status to Lexicon Pharmaceuticals for LX1033, an orally-delivered small molecule drug candidate for diarrhea...

FDA Uses Regulatory Science to Deny ANDA Petition

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Citing regulatory science advancements, FDA denies a Valeant Pharmaceuticals citizen petition asking the agency to not approve any...

FDA Drug Safety Alert on Jazz Xyrem

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An FDA drug safety alert reminds healthcare professionals and patients that Jazz Pharmaceuticals Xyrem should not be used in combi...

FDA Clears Quidel C. Difficile Assay

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FDA clears a Quidel Corp. 510(k) for its non-instrumented molecular diagnostic test, the AmpliVue C. difficile Assay.