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Bill Would Limit Commissioners Terms, Boost Innovation

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Sen. Kay Hagan proposes legislation to set a fixed six-year term for the FDA commissioner and create new drug approval pathways.

LASIK Facility Warned About MDR Violations

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FDA warns Laser Eye Care of California about medical device reporting violations at its laser surgery facility.

Consumers Union Wants Medical Device Safety Reforms

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Consumers Union calls on Congress to strengthen, rather than weaken, medical device safety requirements.

Geron Focusing on Cancer, Ending Spinal Cord Trial

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Geron says it is ending enrollment in its stem cell spinal cord injury trial to concentrate on two oncology drugs.

FDA Says Intellipharmaceutics Canadian Facility is Acceptable

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FDA has given acceptable status to an Intellipharmaceutics drug manufacturing facility.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Leslie Diaz, Laser Eye Care of CA, Medical Compression Systems, Rainbow Ltd dba ...

QS Violations Found at Taiwanese Medical Device Firm

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FDA warns Taiwans Vega Technologies about Quality System violations in its manufacturing of nebulizers and thermometers.

FDA Closely Monitoring Predaxa Adverse Events

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FDA says it is keeping a close eye on fatal bleeding cases associated with Boehringer Ingelheims Pradaxa, indicated for preventing...

FDA Alumni Assn. Gives Media the Boot

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In what may be the latest example of FDAs dwindling transparency, the FDA Alumni Association forbids news media coverage of its me...

OMB OKs Info on Orphan Drug Form

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Federal Register Notice: The Office of Management and Budget approves a collection of information on orphan drugs and a common Eur...