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Court Orders FDA Hetlioz Action

[ Price : $8.95]

The DC federal court orders FDA to act on a Vanda sNDA for a Hetlioz indication to treat jet lag disorder or schedule a hearing on...

CAR T-Cell Development Considerations Guide

[ Price : $8.95]

FDA posts a guidance entitled Considerations for the Development of Chimeric Antigen Receptor T Cell Products.

Guide on Race/Ethnicity Data Reporting

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FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regul...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Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question ...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

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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.