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Inspections Reviewing More Promo Materials: Law Firm

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FDA increases its surveillance of promotional materials during inspections, according to a client bulletin by Arnall Golden Gregor...

Meeting Set for Schizophrenia Trial Considerations

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FDA announces an 8/16 public meeting on Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials to discuss approaches...

Eugia Pharma Gets Fourth FDA-483 in 2024

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FDA issues Eugia Pharma Specialities its fourth Form FDA-483 of the year after concluding an inspection of the firms formulation m...

Giron Debarred Over Investigator Misconduct

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Federal Register notice: FDA issues an order permanently debarring Angela Maria Giron from providing services in any capacity to a...

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Hyman, Phelps & McNamara senior medical device regulation expert Lisa Baumhardt critiques a recent FDA draft guidance on the Q-Sub...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