Federal Register notice: FDA issues a final rule amending requirements for medical device premarket submissions to require a single submission in elec...
Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology D...
FDA authorizes the de novo marketing of Tandem Diabetes Cares Control-IQ Technology, an interoperable automated glycemic controller device that adjust...
Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterili...
FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.
FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.
Futura Medical says it intends to discuss with FDA a medical device regulatory approval pathway for the placebo arm from an erectile dysfunction Phase...
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH...