CDRH officials say they are looking to identify the least amount of information that device companies need to support a declaration of conformity to a...
FDA grants Neuro Event Labs a breakthrough device designation for its Nelli, a device designed to automate the identification of seizure events.
Several health experts criticize FDAs recent guidance on minimum requirements for Covid-19 vaccines to obtain an emergency use authorization (EUA), sa...
The Western Virginia District Court sentences former Indivior CEO Shaun Thaxter to six months in federal prison for his role in causing the introducti...
FDA sends For Our Vets (Mesa, AZ) a Warning Letter after reviewing its Web site and social media sites and determined that it offers CBD products for ...
FDA sends New Delhi-based Aurobindo Pharma a Warning Letter citing its U.S subsidiary AuroLife Pharma based on an inspection at its oral solid manufac...
Federal Register notice: FDA sends to OMB an information collection extension for Additional Criteria and Procedures for Classifying Over-the-Counter ...
Federal Register notice: FDA makes available an annual compilation of updates to the agencys Susceptibility Test Interpretive Criteria Web page.