Federal Register notice: FDA announces a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Comm...
FDA issues a draft guidance to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway.
Federal Register notice: FDA announces a 4/10/2019 public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Sta...
FDA issues 63 new and revised product-specific guidances to promote development of generic drugs.
FDA warns Corona Doctors Medical Clinics about objectionable conditions in its conduct of a clinical investigation.
FDA approves an Ortho Clinical Diagnostics expanded indication for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use ...
FDA clears an electroCore 510(k) for an expanded label for gammaCore vagus nerve stimulator therapy for adjunctive use for preventing cluster headache...
FDA issues a draft guidance to update Section V of a 2008 CLIA Waiver guidance.