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FDA Agrees to Some Selenium Cancer Claims

[ Price : $8.95]

FDA agrees to some site-specific cancer claims for selenium as required by a federal court decision.

FDA Clears Abbott's RevitaLens Contact Cleaner

[ Price : $8.95]

FDA clears an Abbott 510(k) for its RevitaLens Ocutec multi-purpose disinfecting contact lens solution.

Santarus and Cosmo Pharma Plan NDA for Colitis Drug

[ Price : $8.95]

Santarus and Cosmo Pharmaceuticals plan an NDA submission after reporting positive Phase 3 clinical study results involving budeso...

FDA 'Orphan' Status for Parasitic Drug

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FDA grants iCo Therapeutics an orphan drug designation for iCo-009 (oral amphotericin B) for treating visceral leishmaniasis.

Health Information Technology Study Includes FDA Role

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The Institute of Medicine contracts for a one-year study of health information technology in patient safety, including FDAs role.

QS Violations Found at Perma Pure

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FDAs New Jersey District Office warns Perma Pure about Quality System and Medical Device Reporting violations in its manufacture o...

Swedish Fetal Heart Monitor Plant Has QS Problems

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FDA warns Neoventa Medical over Quality System and Medical Device Reporting violations in its manufacturing of fetal heart monitor...

FDA Scraps Broad Adverse Event Definition in Trial Reporting Rule

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FDA abandons its proposed definition for a suspected adverse drug reaction (SADR) in a just-finalized rule on clinical trial safet...

Renewed Interest in Separate FDA Drug Safety Center

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Sen. Charles Grassley tells Bloomberg News that data on withdrawn drugs due to increased risk of heart problems demonstrate the ne...

FDA OKs Merial NADA for Equine Osteoarthritis

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Federal Register Final rule: FDA approves a Merial Ltd. NADA for veterinary prescription use of firocoxib injectable for equine os...