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 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...
FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agency is following the ...
FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facili...
