The Congressional Research Service identifies three policy considerations Congress may address in response to complaints from some stakeholders about ...
A research study says FDA may need new strategies for using social media to communicate drug safety messages.
FDA accepts for priority review an Ionis Pharmaceuticals NDA for inotersen, indicated for treating patients with hereditary transthyretin amyloidosis.
CDER director Janet Woodcock says one or more of four expedited review pathways were used by more than half of the novel drugs approved in 2017.
A Pennsylvania state judge overturns a $27.8 million jury award to a couple who alleged that Bayer and Johnson & Johnson failed to adequately warn abo...
FDA approves Medtronics new clinician programmer for use with the SynchroMed II Intrathecal Drug Delivery system, an implantable pump that provides ta...
Federal Register notice: FDA announces a 3/5-6 Risk Communication Advisory Committee meeting to discuss the impact of pregnancy and lactation labeling...
Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an additional two years.