FDA revokes the emergency use authorization of a Chembio Diagnostic System Covid-19 antibody test due to performance concerns with the accuracy of the...
FDA warns three companies they are selling unapproved and misbranded Covid-19 antibody tests.
University of California resident surgeon Nisarg Patel calls on Congress to make FDA an independent agency to help it weather political pressure durin...
FDA approves Novartis Cosentyx (secukinumab) for treating active non-radiographic axial spondyloarthritis.
FDA announces a 9/30 virtual public meeting entitled Patient-Reported Outcomes and Medical Device Investigations: From Conception to Implementation.
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Drug Product Communications as Used by the...
Federal Register notice: FDA sends to OMB an information collection revision for Protection of Human Subjects and Institutional Review Boards; Certifi...
FDA warns Canadas Cosmaceutical Research Lab about CGMP and other violations in its production of finished drugs.