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Drug Compounding Registration Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Registration of Human Drug Compounding...

FDA Denies St. Jude Codeine Use Petition

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FDA denies a St. Jude Childrens Research Hospital request to allow some use of codeine-containing analgesics in patients under age...

More Supplements Risk Oversight Coming: Califf

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FDA commissioner Robert Califf says dietary supplement risk management will be elevated with the integration of the Office of Diet...

Oncopeptides Appealing Drug Withdrawal Request

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Oncopeptides says it is going to file a formal appeal of FDAs recent request for the company to voluntarily withdraw its accelerat...

Priority Review for Venatorx UTI Drug NDA

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FDA sets 2/22/2024 as the PDUFA action date for its priority review of Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to ...

Breakthrough Status for AngioVac System

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FDA grants AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include ...

FDA Extends Review of Chikungunya Vaccine

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FDA extends by three months the review of a Valneva BLA for VLA1553, the companys chikungunya virus vaccine candidate.

Org. Structure for CDRH Strategic Group

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Federal Register notice: FDA announces a modification to the organizational structure of CDRHs Office of Strategic Patnerships and...

Panel to Discuss IVD Reclassifications

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Federal Register notice: FDA announces a 9/7-8 Medical Devices Advisory Committee Microbiology Devices Panel meeting that will dis...

Phillips Recalls Trilogy EVO Ventilators

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Philips Respironics recalls its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt in the air...