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...
Some 29 advocacy groups call on FDA to act quickly to finalize a ban on electric skin shock devices used to treat self-injurious or aggressive behavio...
FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow some records to be c...
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 the submission.
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FDA releases a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Product...
Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question and Answers.
