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Merck Wants FDA Focus on Health Literacy, Then DTC Research

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Merck says FDA should focus its efforts and research first on improving the health literacy of approved patient labeling, and then...

FDA Priority Review for Adapt NDA for Narcan

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FDA accepts for a priority review an Adapt Pharma NDA for Narcan (naloxone hydrochloride) Nasal Spray for use as an emergency trea...

Mini-sentinel Looks at Pediatric Febrile Seizures with Flu Vaccine

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FDA posts a Mini-sentinel protocol that seeks an assessment of the risk of febrile seizures following inactivated influenza vaccin...

Info on E-User Fee Payment Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on electronic use...

Guidance on Investigational Tobacco Products

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Federal Register Notice: FDA releases a draft guidance: Use of Investigational Tobacco Products.

Groups Urge Sec. of State Kerry to Push FDA on Amalgam

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Sixty health and environmental groups ask Secretary of State John Kerry to urge FDA to conform with U.S. policy to reduce dental a...

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.