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FDA Warns Consumers About Infant Sleep Positioners

[ Price : $8.95]

FDA warns consumers to stop using infant sleep positioners due to suffocation risks.

Pfizer Stops Sutent Prostate Cancer Trial

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Pfizer ends a Sutent prostate cancer trial when no benefit is seen in an interim analysis.

FDA Agrees to Some Selenium Cancer Claims

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

FDA Clears Abbott's RevitaLens Contact Cleaner

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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

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

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 Charles Grassley tells Bloomberg News that data on withdrawn drugs due to increased risk of heart problems demonstrate the ne...

Judicial Watch Reports 16 New Deaths With Gardasil

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As part of its ongoing investigation into adverse reactions caused by Merck's human papillomavirus vaccine Gardasil, public intere...