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Supplements Recalled Due to Undeclared Ingredients

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Performance Plus Marketing recalls Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supr...

Guidance on Certification for Medical Gases

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Federal Register Notice: FDA releases a draft guidance, Certification Process for Designated Medical Gases.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Axiobionics, Basic Organics, Leisure Products, and Prime Herbs Corp.

Group Says Hamburg Gave Inaccurate Testimony on Compounding

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Public Citizen says FDA commissioner Margaret Hamburg provided inaccurate testimony about pharmacy compounding last month during C...

FDA Clears Avinger Imaging Catheter

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FDA clears an Avinger 510(k) for its Ocelot PIXL imaging catheter with onboard imaging for crossing chronic total occlusions in pa...

New Medical Device Tax Will Cut Workforce: Survey

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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

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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.