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Young Adults Taking More Rx Meds

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The Agency for Healthcare Research and Quality says the prescription drugs accounted for a higher share of medical expenses for th...

FDA Transparency Has a Long Way to Go

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FDA Webview Washington editor David McFarland examines FDAs refusal to release a letter to Congress on drug reimportation concerns...

CGMPs Regs Released for PET Drugs

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Federal Register Final rule: FDA issues current good manufacturing practice regulations for approved positron emission tomography ...

More Attorneys for FDA: Wasteful Duplication or Something Else?

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Consulting editor John Scharmann reviews the growing number of attorneys being hired by diverse FDA offices for purposes already s...

Advisors Back Gileads Aztreonam Safety, Efficacy

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FDAs Anti-infective Drugs Advisory Committee votes 15-2 to recommend that Gileads aztreonam is safe and effective in treating lung...

FDAers Earning $200K-plus Double in 2 Years

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Our latest FDA salary survey from 2008 agency data obtained under FOIA shows that the agency has doubled in two years the number o...

Abbott sNDA for New Simcor Dosages

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Abbott submits a supplemental NDA for two new dosage strengths (500/40 mg and 1,000/40 mg) of Simcor, its cholesterol-lowering fix...

Bayer Recalls 1 Lot of Alka-Seltzer Gels

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FDA says that Bayer Consumer Care is recalling one lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Li...

Salix Says Rifaximin NDA on Target for 2010

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Salix says it plans to submit an NDA for rifaximin for treating non-constipation irritable bowel syndrome in the first half of 201...

Guidance on Patient-Reported Outcomes

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Federal Register Notice: FDA releases a guidance, Patient-Reported Outcome Measures Use in Medical Product Development to Support ...