FDA acting commissioner Ned Sharpless says the agency is just weeks away from announcing a new plan to modernize its technology infrastructure to help...
FDA denies a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on approval of any new ...
FDA issues two guidances related to medical device de novo classification requests one on performance goals and the other on user fee refund requests...
FDA issues a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products.
FDA says it is developing guidance on data quality issues that pertain to real world data and related study design considerations.
A new GAO report finds that FDA has ongoing efforts to help drug manufacturers identify the circumstances under which they could broaden clinical tria...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for GlaxoSmithKline Biologicals Shingrix vaccine.
Federal Register notice: FDA makes available a final guidance entitled Humanitarian Device Exemption (HDE) Program.