Researchers say inappropriate prescribing of transmucosal immediate release fentanyl products occurred despite a REMS intended to ensure appropriate p...
FDA grants Medtronic a breakthrough device designation for its investigational Personalized Closed Loop insulin pump system.
FDA releases its latest batch of Warning Letters that include Mark Berman and Datascope.
FDA Review posts the Federal Register notices for the week ending 2/15/2019.
FDA Review posts product approval summaries for the week ending 2/15/2019
Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled Framework for a Real-World Evidence Program; Availability.
Federal Register notice: FDA announces a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting that will...
Federal Register notice: CDER provides an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program.