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FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regul...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question ...[ Price : $8.95]
Federal Register notice: FDA makes available a final document entitled Best Practices for FDA Staff in the Postmarketing Safety Su...[ 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...[ Price : $8.95]
U.S. Senator Tammy Baldwin (D-WI) writes the four biggest drug companies marketing asthma inhalers urging them to stop unfairly bl...[ Price : $8.95]
Merck says its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell ...[ Price : $8.95]
Philips Respironics and FDA reach an agreement on the terms of a consent decree over the companys struggles to resolve issues surr...[ Price : $8.95]
FDA issues a guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.