Federal Register notice: FDA makes available a draft guidance entitled Multiple Function Device Products: Policy and Considerations.
Federal Register notice: FDA makes available a guidance entitled Clinical Trial Imaging Endpoint Process Standards.
FDA commissioner Scott Gottlieb says the agencys new internal data science incubator is one of many steps being taken to implement its digital innovat...
CDER Office of Testing and Research senior staff fellow Xiaoming Xu outlines steps being taken to advance nanotechnology in drug development, along wi...
FDA commissioner Scott Gottlieb is pleasing everyone on Capitol Hill, reports Alliance for a Stronger FDA deputy executive Steven Grossman in an analy...
FDA warns Phase 4 Pharmaceutical about CGMP violations in its repackaging of OTC transdermal patch products.
FDA issues a guidance to assist sponsors to optimize the quality of imaging data from clinical trials used to support approval of drugs and biologics.
FDA clears an Agfa 510(k) for its DR 800 multi-purpose imaging system.