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.
FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.
FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does...
