Federal Register notice: FDA determines that 20 drug products were not withdrawn from sale for safety or effectiveness reasons.
California says it will receive $19 million as part of a $189 million Boston Scientific settlement with 47 states and the District of Columbia to reso...
CBER releases its strategic plan for 2021-2025 with four goals that reflect the Centers near-term priorities.
FDA grants Tempus a breakthrough device designation for its artificial intelligence electrocardiogram Analysis Platform.
Exela petitions FDA to reassign a therapeutic equivalence code to its nicardipine NDA product and refund PDUFA user fees that it believes should not h...
Federal Register notice: FDA revises its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need in drug c...
Federal Register notice: FDA announces a 6/23 public workshop entitled FY 2021 Generic Drug Science and Research Initiatives Workshop.
FDA issues a refusal to file letter for a Novo Nordisk semaglutide label expansion application.