FDA says that allowing chemically synthesized peptides to use the biosimilar or interchangeable approval pathway will benefit consumers by bringing fo...
FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adu...
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FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.
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Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology D...