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FDA Clears BD Life Panel to Detect Parasites

[ Price : $8.95]

FDA clears BD Life Sciences BD MAX Enteric Parasite Panel as an aid in diagnosing infectious gastroenteritis.

Vermont Governor Opposes Califf Confirmation

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Vermont Gov. Peter Shumlin calls on the Senate HELP Committee chairman and ranking member to oppose the nomination of Robert Calif...

FDA Expedited Approvals Becoming More Common: Study

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Harvard Medical Schools Aaron Kesselheim says that FDA is making greater use of drug expedited approval programs that rely on lowe...

FDA Emphasizing Software in 510(k)s: Consultant

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Consultant Russ King says that a new FDA guidance on 510(k) acceptance criteria shows the agencys increasing interest in medical d...

Pathway Genomics Challenged Again on DTC Tests

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FDA again questions San Diego-based Pathway Genomics over a new direct-to-consumer genetic testing kit, this one targeting cancer.

Questions on FDA Risk/Benefit Guidance for IDEs

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Three stakeholders offer suggestions to improve an FDA draft guidance on weighing risk versus benefit in IDEs.

Comments Sought on Costs of Biosim Product Review

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Federal Register Notice: FDA seeks comments on an interim study of the workload and costs associated with the review of biosimilar...

Support for FDA Quality Metrics Guidance

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Europes ECA Foundation praises an FDA draft guidance on quality metrics and raises some concerns.

Good Design Makes Graphs, Charts More Useful: FDA

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CBER staffer Richard Forshee praises work done by the FDA Safety Graphics Working Group to apply good graphic design techniques to...

Amgen, Allergan Report Positive Biosimilar Trial Data

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Amgen and Allergan say a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints.