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.
FDA issues a draft guidance on Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which proposes a process where device compa...
FDA accepts for priority review a Merck supplemental BLA for Keytruda for use in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for ...
FDA posts two final guidance documents on regenerative medicine therapies as part of the agencys comprehensive regenerative medicine policy framework....