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FDA OKs Levaquin Expanded Indication

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FDA approves Ortho-McNeils Levaquin 750 mg intravenous and oral use under a five-day, once-daily regimen for treating complicated ...

Colin Powell in TAP Prostate Program

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Colin Powell appears in Prostate Cancer Education Council public service announcements promoting yearly prostate cancer checkups f...

Von E Warns FDAers of Possible Layoffs

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FDA commissioner Andrew von Eschenbach warns employees that nearly 2,000 of them might have to be laid off if Congress doesnt reau...

B. Braun Recalls Saline Syringes

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B. Braun Medical recalls two sizes of saline flush syringes that have visible silicone particulate matter in them.

FDA Part of ADHD Medicine Heart Study

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FDA and AHRQ are investigating whether ADHD drugs increase cardiovascular risk in children or adults.

Former ACRA Taylor Moves to BIO

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Former FDA associate commissioner for regulatory affairs John Taylor III resigns his government affairs post at Abbott to join Bio...

CU Challenges White House on Drug Trial Results

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Consumers Union says White House opposition to requiring drug companies to make trial results public is shocking.

Info on PMA Approval Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket approval of medical devices to the Office o...

Comments Reopened on IVD Assay Guidance

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Federal Register Notice: FDA reopens the comment period for a draft guidance on in vitro diagnostic multivariate index assays.

Guidance on Commercial Analyte Specific Reagents

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Federal Register Notice: FDA releases a guidance on frequently asked questions for commercially distributed analyte specific reage...