CDER and CBER say they have accepted the first artificial intelligence, digital health technology, and neuroscience project in the ISTAND pilot for de...
FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for animal drug APIs.
FDA purchases a subscription to digiM Solutions I2S software for the CDER Division of Product Quality and Research.
Five stakeholders suggest possible topics for an upcoming FDA workshop on innovative drug clinical trials.
Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries call on Congress to hold a hearing to understand the agencys app...
FDA publishes an updated guidance incorporating GDUFA 3 performance goals on amendments and requests for final approval to tentatively approved ANDAs.
FDA sends Theratechnologies a complete response letter on its supplemental BLA for an F8 formulation of Egrifta SV (tesamorelin), indicated for reduci...
Federal Register notice: FDA sends to OMB an information collection extension entitled Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis...
