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Human Drugs

Guide on Race/Ethnicity Data Reporting

FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Product...

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Federal Register

Remote Regulatory Assessments Q&A Guide

Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question and Answers.

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Federal Register

Safety Surveillance Best Practices Document

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

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Human Drugs

Paxlovid EUA Modified to Move to NDA Product

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

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Human Drugs

Senator Targets Firms Over Improper Patents

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

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Human Drugs

Positive Data in Keytruda Kidney Cancer Trial

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

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Medical Devices

Philips Respironics, FDA Reach Consent Decree

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

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Human Drugs

Human Genome Editing Product Development Guide

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

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Human Drugs

Azurity Pharma Recalls 1 Lot of Zenzedi

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

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Biologics

Merck Keytruda Data Positive in Bladder Cancer

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