Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Pr...
Federal Register notice: FDA makes available a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies f...
FDA lifts a 2022-imposed clinical hold against INmune Bios XPro (XPro1595; pegipanermin) and its Alzheimers disease clinical trial.
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FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Product...
Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question and Answers.
