Federal Register notice: FDA sends to OMB an information collection extension for Postmarket Surveillance of Medical Devices 21 CFR Part 822.
Harvard researchers say biosimilars are often approved by FDA before they are approved in Europe.
FDA approves BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010.
FDA announces a 12/5 public meeting on its Standard Core Clinical Outcome Assessments and Endpoints Pilot Grant Program.
Researchers argue for expanded FDA regulation of health apps to prevent harm to consumers.
FDA grants Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia.
The National Council on Disability says FDA and other federal agencies should have active oversight over prenatal genetic testing.
Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohns disease drug PRV-6527 showed that the therapy did not perform bett...