FDA publishes an International Conference on Harmonization guidance on planning and designing multiregional clinical trials.
FDA publishes a draft guidance with questions and answers on requirements for NDA and ANDA applicants to submit field alert reports under specific con...
FDA clears an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use i...
FDA accepts for priority review an Immunomedics BLA for sacituzumab govitecan and its use in treating patients with metastatic triple-negative breast ...
Federal Register notice: FDA has made available a draft guidance entitled Innovative Approaches for Nonprescription Drug Products.
Stakeholders respond to an FDA request for comment on software excluded from regulation under the 21st Century Cures Act.
Stakeholders offer varied comments on and requests for changes to an FDA proposed rule on product jurisdiction.
FDA approves a Janssen NDA for Symtuza (darunavir), a single-tablet regimen for treating human immunodeficiency virus type 1 in treatment-nave and cer...