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FDA Panel Criticizes Bayer, FDA Over Essure Device

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FDA and Bayer receive major criticism from an FDA advisory committee for not requiring or conducting a randomized clinical trial t...

IDE Review Times Still Improving: Officials

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CDRHers Jeffrey Shurin and Owen Faris discuss three Center actions that have led to faster IDE reviews and approvals.

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Federal Register Notice: FDA releases a draft guidance: Use of Investigational Tobacco Products.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

Professional Groups Rebuff FDA on Testosterone

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Two professional endocrinology groups say they disagree with a March FDA caution about not prescribing testosterone replacement th...

FDA Revises Tobacco Environmental Impact Regs

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Federal Register Final rule: FDA revises regulations to allow certain classes of actions on tobacco product applications to be exc...