FDA releases a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suit...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 releases five guidances relating to expanding the 510(k) program that the Safety and Performance Based Pathway.
FDA solicits comments on abuse-deterrent formulations for prescription stimulants.