Bloomberg Law says the Justice Department is looking into the use of AI in electronic health records to push doctors to prescribe particular treatment...
FDA accepts for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treating adult patients wi...
FDA posts a guidance entitled Considerations for the Development of Chimeric Antigen Receptor T Cell Products.
FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Product...
Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question and Answers.
Federal Register notice: FDA makes available a final document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human ...
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...
U.S. Senator Tammy Baldwin (D-WI) writes the four biggest drug companies marketing asthma inhalers urging them to stop unfairly blocking generics from...
