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FDA Expands Program on Medical Product Safety

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Federal Register Notice: FDA plans to expand its Conference Cooperative Agreement Program, awarded to the Brookings Institution to...

JAMA Study on OTC Labeling Finds Inconsistencies

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A new study reported online in the Journal of the American Medical Association finds high levels of variability and inconsistency ...

FDA Amends Regs to Include Tobacco

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Federal Register Direct final rule: FDA amends it s regulations to include tobacco products where appropriate.

Comment Sought on National Stockpile Regulations

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Federal Register Notice: FDA seeks comments on information collection requirements on labeling requirements for products held by t...

Comments Sought on FDA Focus Group Info

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Federal Register Notice: FDA seeks comments on FDA focus groups used to gauge public opinion on FDA-regulated products.

Comments Sought on Radioactive Drug Regs Info

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Federal Register Notice: FDA seeks comments on the information collection in regulations on the use of radioactive drugs for basic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Align Technology, Anchor Products Co., Energy Technology, and Gunnell.

Align Technology Warned on MDR Violations

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FDAs San Francisco District Office warns Align Technology of Medical Device Reporting violations associated with its Invisalign Sy...

Class 1 Recall for B. Braun addEASE Binary Connectors

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FDA posts a 6/28 urgent Class 1 recall of B. Brauns fluid transfer addEASE binary connector because stopper fragments may enter a ...

Panel to Discuss Electroconvulsive Therapy Devices

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Federal Register Notice: FDAs Neurological Devices Panel will meet 1/27-28/11 to discuss reclassifying electroconvulsive therapy d...