FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Product Compliance Policy.
FDA Review posts the Federal Register notices for the week ending 9/20/2019.
FDA Review posts product approval summaries for the week ending 9/20/2019.
Darmerica recalls two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient due to a label mix-up.
Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous system stimulants.
Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency device Safety and Performance Based Pathw...
FDA releases a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suit...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.