FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations in its conduct of no...
Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.
Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation ...
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.
FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computational modeling and simul...
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...
