Former FDA deputy commissioner for global regulatory operations and policy Howard Sklamberg says companies should expect a continued FDA emphasis on e...
FDA clears a Masimo 510(k) for home use of the Rad-97 Pulse CO-Oximeter.
FDA clears an Attune Medical 510(k) for its EnsoETM, a device capable of administering tube feeds or medication while simultaneously cooling or warmin...
International Laboratories recalls one lot of clopidogrel tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabel...
A Tufts Center for the Study of Drug Development survey finds that drug development is being challenged by data issues involving new electronic data c...
CBER director Peter Marks says the Center approved four therapeutic firsts in FY 2017, including the first U.S. gene therapy.
FDA releases its latest batch of Warning Letters that includes one to American CryoStem.
Federal Register notice: FDA submits to OMB for clearance an information collection for Medical Devices; Humanitarian Use Devices 21 CFR Part 814 OMB...