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Q-Submission Guide Step in the Wrong Direction: Expert

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Hyman, Phelps & McNamara senior medical device regulation expert Lisa Baumhardt critiques a recent FDA draft guidance on the Q-Sub...

Office of Translational Sciences Annual Report

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The CDER Office of Translational Sciences 2023 annual report lists achievements in seven program areas.

Mass Spectrometry Guide for Animal Drugs

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FDA posts a final guidance entitled Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.

Bill to Ban Tianeptine as a Supplement

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Sens. Durbin and Blumenthal introduce legislation to authorize FDA to ban the marketing of tianeptine, currently being sold as a d...

Thoratec Recalls HeartMate 3 and LVAS Implant Kit

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Abbotts Thoratec unit recalls its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak.

Apple Watch Qualified for AFib Trial Monitoring

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CDRH qualifies the Apple Watchs Atrial Fibrillation History Feature as a medical device development tool for use as a biomarker te...

Info Collection on New Animal Drug Regs

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Federal Register notice: FDA seeks comments on an information collection extension entitled New Animal Drugs for Investigational U...

Praise, Suggestions for Informed Consent Guide

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Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed c...

Decentralized Trials Time Has Come: Marks

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CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical tria...

Use Accelerated Approval for Rare Diseases: Commentary

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A National Mucopolysaccharidoses Society commentary urges FDA to use accelerated approval for promising treatments for rare diseas...