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Lawsuit Seeks REMS Removal on Mifepristone

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A multistate lawsuit seeks FDAs removal of REMS restrictions on medical abortion drug mifepristone.

Pfizer/BioNTech sBLA for Harmonized Covid Shot

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Adhering to an FDA advisory committee recommendation last month, Pfizer and BioNTech file a supplemental BLA that seeks approval o...

Panel to Vote on Converting Paxlovid EUA to Traditional Approval

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A Pfizer NDA seeking traditional approval for its Covid-19 drug Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) heads to...

Guide on Wet Age Macular Degeneration Drugs

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FDA posts a draft guidance on wet age-related macular degeneration drug development.

Califf Pushes Improved Evidence Generation System

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FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapidly advancing artificial intell...

Human Factor Guidance is FDA Mission Creep: Attorney

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Attorney Jeffrey Shapiro says FDA is using a new draft guidance to significantly expand the instances when human factors data must...

Octapharma Submits Wilate sBLA

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Octapharma USA submits an sBLA for an expanded indication for its Wilate von Willebrand disease bleeding control drug.

PhRMA Proposes Changes to M11 Guidance

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PhRMA gives FDA specific comments and edits on the International Council for Harmonization M11 protocol. Template, and technical s...

CMS Continues Block on Alzheimers Drug Coverage

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The Centers for Medicare & Medicaid Services says it is not reconsidering its national coverage determination that restricts Medic...

FDA Urged to Pull Failed Cancer Drugs Faster

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University of Pennsylvania researchers call on FDA to act more quickly when accelerated approval cancer drugs fail confirmatory te...