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Human Drugs

Lawsuit Seeks REMS Removal on Mifepristone

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

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Biologics

Pfizer/BioNTech sBLA for Harmonized Covid Shot

Adhering to an FDA advisory committee recommendation last month, Pfizer and BioNTech file a supplemental BLA that seeks approval of their Omicron BA.4...

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FDA General

Panel to Vote on Converting Paxlovid EUA to Traditional Approval

A Pfizer NDA seeking traditional approval for its Covid-19 drug Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) heads to a 3/16 Antimicrobia...

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Human Drugs

Guide on Wet Age Macular Degeneration Drugs

FDA posts a draft guidance on wet age-related macular degeneration drug development.

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EIRS/483s

Califf Pushes Improved Evidence Generation System

FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e...

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Medical Devices

Human Factor Guidance is FDA Mission Creep: Attorney

Attorney Jeffrey Shapiro says FDA is using a new draft guidance to significantly expand the instances when human factors data must be part of a 510(k)...

Human Drugs

Octapharma Submits Wilate sBLA

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

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Human Drugs

PhRMA Proposes Changes to M11 Guidance

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

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Human Drugs

CMS Continues Block on Alzheimers Drug Coverage

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

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Human Drugs

FDA Urged to Pull Failed Cancer Drugs Faster

University of Pennsylvania researchers call on FDA to act more quickly when accelerated approval cancer drugs fail confirmatory tests to cut the time ...