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FDA Clears Amedica Spinal Implant

[ Price : $8.95]

FDA clears an Amedica Corp. 510(k) for the Valeo ceramic VBR spinal implant.

Precision Biometrics Marketing Unapproved Devices

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CDRH warns Precision Biometrics it is marketing two devices for a new indication without the required premarket approval.

Can Patients be Trusted with OTC Mevacor?

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Two FDA advisory committees will consider 12/13 whether consumers can be trusted to properly obtain and use an OTC version of Merc...

FDA Wants More Andara Info

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FDA asks Cyberkinetics Neurotechnology Systems for more data to support its HDE application for the Andara oscillating field stimu...

New Study is Bad News for Diabetes Drugs

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A new Canadian study finds that popular diabetes drugs Avandia and Actos are associated with increased risks of heart failure, hea...

Comments Sought on Corrections and Removals Reports

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Federal Register Notice: FDA seeks comments on information collection requirements on reports of corrections and removals.

Comments Sought on Rx Advice to Pregnant/Nursing Women

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Federal Register Notice: FDA seeks comments on the information collection provisions on communicating with health care providers a...

Info on Radioactive Drug Research Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on radioactive drug research committees to the Office of M...

Info on Pharmacogenomic Data Submissions Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a guidance on pharmacogenomic data submissions for the ...

FDA Sends Info on NADA Presubmission Conferences to OMB

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Federal Register Notice: FDA sends a proposed collection of information on presubmission conferences on new animal drug applicatio...