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FDA Expands Use of Medtronic Freezor Cryoablation

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FDA approves Medtronic expanded indications for its Freezor and Freezor Xtra Cardiac Cryoablation Focal Catheters for treating ped...

Biosimilar Program Review Finds Higher First-Cycle Approvals

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An independent review of FDAs user fee program for biosimilars finds that first-cycle approval rates were higher during the first ...

Panel to Discuss Amylyx NDA for ALS

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Federal Register notice: FDA announces a 3/30 Peripheral and Central Nervous System Drugs Advisory Committee to discuss an Amylyx ...

Device QSR Modernization/Harmonization Meeting

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Federal Register notice: FDA sets a 3/2 Device Good Manufacturing Practice Advisory Committee meeting to discuss and make recommen...

FDA Says Bellavista Ventilator Recall is Class 1

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FDA says a Vyaire Medical recall of 2,605 Bellavista ventilators due to a software configuration issue is Class 1.

FDA Defers New Drug Manufacturing Reporting Deadline

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FDA defers a 2/15 deadline on new annual drug manufacturing reporting that were mandated by the CARES Act to help the agency get a...

Variability in Sex-Based Drug Difference Info

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University of Maryland researchers find substantial variability in information on sex-based differences in drug safety and efficac...

Acadia Re-files Nuplazid sNDA for Alzheimers

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Acadia Pharmaceuticals resubmits a supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associat...

FDA OKs Avita Recell System PMA Supplement

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FDA approves an Avita Medical PMA supplement for an enhanced version of its Recell system.

Califf Sworn In as FDA Commissioner

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Robert Califf begins his second tour as FDA commissioner after being sworn in 2/17.