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Paxlovid EUA Modified to Move to NDA Product

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FDA says that beginning 3/8, Pfizers Paxlovid that is labeled under a 12/2021 emergency use authorization will no longer be author...

Senator Targets Firms Over Improper Patents

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U.S. Senator Tammy Baldwin (D-WI) writes the four biggest drug companies marketing asthma inhalers urging them to stop unfairly bl...

Positive Data in Keytruda Kidney Cancer Trial

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Merck says its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell ...

Philips Respironics, FDA Reach Consent Decree

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Philips Respironics and FDA reach an agreement on the terms of a consent decree over the companys struggles to resolve issues surr...

Human Genome Editing Product Development Guide

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FDA issues a guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.

Azurity Pharma Recalls 1 Lot of Zenzedi

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Azurity Pharmaceuticals recalls one lot of narcolepsy drug Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg after a repo...

Merck Keytruda Data Positive in Bladder Cancer

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Merck says data from its Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating Keytruda (pembrolizumab) are favorable for the ...

De Novo OK for Google Phone Thermometer

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FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.

Postmarketing Drug Surveillance Best Practices

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FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biologica...

FDA Should Identify AI Legislative Changes: GAO

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A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to ...