FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection...
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scient...
FDA releases the form FDA-483 with six observations from an inspection at Chinas Bio-Thera Solutions.
FDA awards Partner Therapeutics a Commissioners National Priority Voucher for a new Bizengri indication.
FDA publishes a guidance explaining how the agency uses a flexible chemistry, manufacturing, and controls approach to help expedite the development, r...
FDA hosts a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the use of artificial inte...
FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic im...
Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.
