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FDA and Office of Human Research Protection Respond to Fetal Dex Complaint

The September issue of The American Journal of Bioethics, presaged by such astonishing articles as “The Lesbian Drug” in Newsweek, stretched the boundaries of the Journal by engaging questions about...

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Coming Soon: Skull and Crossbones on Your Coke?

That purveyor of ideas all in the name of the “public’s interest”, the Center for Science in the Public Interest is calling for FDA Commissioner Margaret Hamburg to mandate warning labels on none other...

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Dirty Windows of Drug Development

Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and...

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Marketing Off-Label Uses to Physicians: FDA’s Draft (Mis)Guidance

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Marketing Off-Label Uses to Physicians: FDA’s Draft (Mis)Guidance

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Blood Donation, Deferral, and Discrimination: FDA Donor Deferral Policy for...

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A Response to Commentaries on ?Blood Donation, Deferral, and Discrimination?

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FDA Told to Act on Farm Antibiotics

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FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics

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Better Ways Needed to Track Drug Safety: Report

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FDA recommended to continue monitoring drugs’ safety after approval

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IOM calls for more thorough safety monitoring of drugs

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FDA Issues Warning About Experimental MS Therapy

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FDA panel backs at-home HIV test that analyzes mouth swab in 20 minutes

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The Fat-That-Must-Not-Be-Named

by Craig Klugman, Ph.D. As you may have heard, the FDA is considering changing its recommendations concerning partially hydrogenated oils, or what are commonly known as trans fats. The FDA proposes...

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New Painkiller Rekindles Addiction Concerns

[New York Times] The abuse of prescription painkillers has reached epidemic proportions in America. Nearly half of the nation’s 38,329 drug overdose deaths in 2010 involved painkillers like hydrocodone...

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State Defends Ban on Powerful Painkiller Zohydro

<p>The governor of Massachusetts <a...

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Nobel laureate Yamanaka denies image manipulation in 2000 paper

Original commentary by BEI Young Professionals Olivette Burton MBe MSW Asking for forgiveness rather than permission is, unfortunately, becoming a recurring international theme in the world of...

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Advocating Pill, U.S. Signals Shift to Prevent AIDS

[The New York Times]Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus...

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Teen Suicide Attempts Rise as Warning Cuts Medicine Use

[Bloomberg] A widely publicized warning by U.S. regulators a decade ago about risks for teenagers taking antidepressants led to plummeting prescriptions and increased suicide attempts, Harvard...

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