Federal Register notice: FDA announces modifications to its list of standards the agency recognizes for use in premarket reviews.
FDA grants Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to provide preservation, ...
FDA publishes a draft guidance explaining its enforcement discretion for dietary supplements containing N-acetyl-L-cysteine.
NBC News reports FDA may authorize Covid vaccinations for children under age 5 in June.
FDA issues a finalized guidance on developing human drug products that contain nanomaterials.
FDA accepts a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating patients with anemia rel...
An FDA advisory panel unanimously votes to recommend that the agency require future approvals of phosphatidylinositol 3-kinase (PI3K) inhibitors be su...
The National Evaluation System for Health Technology Coordinating Center is partnering with Aetion on a five-year strategic effort to advance the use ...