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PMRs and PMCs Generally on Schedule: FDA Report

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FDA says most applicants completed or released most of the premarketing requirements or commitments reported in the agencys FY 202...

Info Collection on FDA Social/Behavioral Research

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Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral ...

Par Recalls 7 Treprostinil Lots

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Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone p...

Exactech Recalls Equinoxe Shoulder Devices

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Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities unused inventory.

FDA Warns on OTC Anti-choking Devices

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FDA warns against the use of over-the-counter anti-choking devices because they are not approved or cleared by the agency.

Royal Philips Zenition 30 Imager Cleared

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FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.

Panel to Review Colon Cancer Blood Test

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FDA announces that its Medical Devices Advisory Committees Molecular and Clinical Genetics Panel is scheduled to review a Guardant...

Complete Response' on Abeonas PZ-Cel BLA

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FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional inf...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.

FDA OKs Merck Kidney Cancer Drug

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FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...