Federal Register notice: FDA announces an 11/19 public meeting Webcast entitled CBD and Other Cannabinoids: Sex and Gender Differences in Use and Resp...
FDA alerts health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma So...
FDA releases its latest batch of Warning Letters that include Coupler Enterprises and HNC Products.
The Washington Post reports that FDA will issue a new guidance for Covid-19 vaccines that will tighten emergency authorization standards and most like...
FDA grants Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System.
FDA adds content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Heal...
Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the safety labeling of intrau...
Federal Register notice: FDA makes available a replacement final guidance entitled Investigational Covid-19 Convalescent Plasma.