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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...

FDA Clears BD Life Panel to Detect Parasites

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

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Federal Register Notice: FDA releases a draft guidance: Use of Investigational Tobacco Products.

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...