FDA calls for a breast implant Boxed Warning and other labeling changes to help ensure that patients have information needed to make an informed decis...
FDA issues a draft guidance explaining its legal authority to require certain postmarketing studies and clinical trials for certain prescription drugs...
Federal Register notice: FDA seeks comments on an information collection extension entitled Premarket Approval of Medical Devices.
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.