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Guide on Race/Ethnicity Data Reporting

[ Price : $8.95]

FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regul...

Remote Regulatory Assessments Q&A Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question ...

Safety Surveillance Best Practices Document

[ Price : $8.95]

Federal Register notice: FDA makes available a final document entitled Best Practices for FDA Staff in the Postmarketing Safety Su...

Paxlovid EUA Modified to Move to NDA Product

[ Price : $8.95]

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 ...