FDA releases a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suit...
FDA approves Novo Nordisks Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 diabetes.
The Senate Appropriations Committee approves an FY 2020 FDA appropriations bill, which includes $3.148 billion in discretionary funding for the agency...
FDA approves package size and package type limits for over-the-counter forms of loperamide, indicated for controlling symptoms of diarrhea.
Former CDRH director John C. Villforth passes at the age of 88.
FDA issues a proposed rule setting requirements related to the content, format and review and communications procedures for premarket tobacco product ...
FDA clears a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition imaging.
FDA releases five guidances relating to expanding the 510(k) program that the Safety and Performance Based Pathway.