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Guidances Post for Covid-19 Emergency

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Federal Register notice: FDA makes available guidance documents related to the Covid-19 (XXX U/lc XXX) public health emergency.

Chiesi Rare Diseases NDA Approved

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FDA approves a Chiesi Global Rare Diseases NDA for Ferriprox (deferiprone) twice-a-day tablets for treating patients with transfus...

CDRH Discontinuance, Interruption Notification Explained

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A CDRH Webinar explains which medical device manufacturers are required to notify FDA of a permanent discontinuance or interruptio...

ValeoMD Selling Unapproved Stem Cell Therapy: CBER

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CBER cautions ValeoMD that it is marketing a human cell, tissue, or cellular or tissue-based product without the necessary BLA or ...

FDA Artificial Intelligence RFI

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FDA issues an RFI for a contractor to deploy artificial intelligence-based capabilities to support CDER drug product assessments a...

CalciMedica Advancing Covid-19 Drug Trial

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CalciMedica says it is transitioning an ongoing randomized open-label study to a blinded placebo-controlled trial for Auxora (in p...

Trump Wants Drug Pricing Bill, Grassley Says

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Sen. Chuck Grassley says President Trump said at a Republican senatorial luncheon that he still wants to see drug pricing legislat...

FDA Improving (Q)SAR Models

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FDA says that drug developers are interested in applying (quantitative) structure-activity relationship models that have been impr...

Covid PMA or HDE Supplement Guidance

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FDA issues an immediately-in-effect guidance to help address manufacturing limitations or supply chain issues arising from the Cov...

FDA Posts List of Removed Antibody Tests

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FDA releases a list of antibody tests that the agency expects will not be marketed or distributed for several reasons.