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Info Collection Extension for Biosimilar Applications

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Federal Register notice: FDA submits to OMB an information collection extension for General Licensing Provisions; Section 351(k) B...

FDA Turns Down Generic Tadalafil Oral Film

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FDA issues Aquestive Therapeutics a complete response letter on its NDA tadalafil oral film, a PDE5 inhibitor currently marketed (...

FDA Proposes Simple Pathway for Drug-related Digital Tech

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FDA seeks input on how it can promote the development of digital technologies that would guide safe and effective prescription dru...

AstraZeneca/MedImmune Miss on Phase 3 MYSTIC Trial

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AstraZeneca and MedImmune say results from their Phase 3 MYSTIC trial involving Imfinzi (durvalumab) in lung cancer did not meet p...

Sen. Enzi Seeks Details on FDA Succession Plan

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Senator Mike Enzi (R-WY) writes FDA commissioner Scott Gottlieb expressing concern over eventual senior staff turnover and asking ...

Seattle Genetics sBLA for Adcetris OKd in 2 Weeks

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In less than two weeks after submitting a supplemental BLA, FDA approves a Seattle Genetics submission for Adcetris (brentuximab v...

Petition Seeks to Block Chronic-use Opioids

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Pharmaceutical Manufacturing Research Services petitions FDA asking it to not approve any opioid product seeking an indication or ...

Annual Report on Post Marketing Requirements/Commitments

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Federal Register notice: FDA announces the availability of its annual report entitled Report on the Performance of Drug and Biolog...

Consumer Reps Needed for Advisory Committees

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...

FDA Posts PMA, HDE Approval Notices

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Federal Register notice: FDA publishes a list of PMAs and humanitarian device exemption applications that have been recently appro...