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...
FDA warns Czechias Respilon Production about CGMP violations in its manufacturing of over-the-counter drugs.
A Bioprocess Online guest column outlines recent changes to FDAs accelerated approval pathway that were made to address systemic failures in the pathw...
