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Participants Sought to Select Tobacco Panel Reps

[ Price : $8.95]

Federal Register Notice: FDA is requesting participants to help select nonvoting industry representatives for the Tobacco Products...

FDA Clears RenovoRx RC120 Catheter

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FDA clears a RenovoRx 510(k) for its RenovoCath RC120 catheter, intended for isolating blood flow and delivering fluids.

FDA Grants Fast Track on Novavax Vaccine

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FDA grants Novavax a fast track designation for its H7N9 virus-like particle vaccine candidate (H7N9 VLP) adjuvanted with Matrix-M...

Data Sharing in Medical Product Development

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A Georgetown University report promotes voluntary data sharing as a way to benefit medical product development.

Ex-FDAer John Taylor Joins Regulatory Consulting Firm

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Former FDA counselor to the commissioner John Taylor joins Greenleaf Health as compliance and regulatory affairs principal.

FDA Refutes Takeda Safety Challenge Over Colcrys Competitor

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FDA says it did not err when it approved Hikma Pharmaceuticals 505(b)(2) application last month for Mitigare (colchicine) capsules...

Real World Data Help Effective Drug Use: Conference

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Presenters on a European Health Forum panel say real world data can change the way drugs are developed, approved, and prescribed.

FDA Grants Kamada Orphan Status for Glassia

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FDA grants Kamada Ltd. an orphan drug designation for Glassia, the companys proprietary human Alpha-1 Antitrypsin for treating Gra...

FDA OKs First Vaccine for Serogroup B Meningococcal Disease

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FDA approves Wyeth Pharmaceuticals Trumenba, the first vaccine in the U.S. to prevent invasive meningococcal disease caused by Nei...

FDA Sends Collection of Info on Biologic AERs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on adverse experience reporting for licensed biological ...