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Recovered Covid Patients Should Donate Plasma: Hahn

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FDA commissioner Stephen Hahn calls on recovered Covid-19 patients to donate blood plasma to be used in developing a convalescent ...

Device User Fee Reauthorization Meeting Postponed

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FDA postpones a 5/5-planned public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.

FDA Maintaining User Fee Activities

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FDA commissioner Stephen Hahn says the agency staff is keeping up with user fee review activities but may have to cut back due to ...

CVM Goes After Unapproved Chloroquines

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CVM warns two companies they are illegally distributing choloroquine phosphate products that are considered to be unapproved anima...

Mayne Pharma NDA for New Contraceptive

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Mayne Pharma files an NDA for E4/DRSP (estetrol and drospirenone), an oral contraceptive indicated for preventing pregnancy.

Web Site Could Help Covid Drug Trials: Activists

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Three healthcare activists say FDA and NIH must start enforcing the FDAAA provision requiring clinical trial data to be submitted ...

510(k) Information Collection Procedures Revised

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Federal Register notice: FDA submits to OMB an information collection revision entitled Premarket Notification Procedures 21 CFR ...

Info Collection on Pediatric Device Submissions

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Federal Register notice: FDA sends to OMB an information collection extension for pediatric- uses of medical devices submissions.

Bayer Chloroquine Donation Questioned

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Government and independent sources say FDA accepted a donation of millions of Bayer chloroquine tablets made in facilities in Indi...

Regeneron Priority Review for Ebola Therapy

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FDA accepts for priority review a Regeneron Pharmaceuticals BLA for REGN-EB3, an investigational triple antibody cocktail for trea...