FDA clears an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology, a new cardiac mapping platform designed to help physicians bett...
FDA releases an FDA-483 with seven observations from an inspection at Longview, TX-based Med Shop Total Care.
Federal Register notice: FDA corrects a notice in the 11/1/2021 Federal Register that announced the regulatory review period for Daiichi Sankyos Enher...
FDA warns against using unapproved LuSys Laboratories Covid-19 tests due to a potentially high risk of false results.
FDA and the Duke-Margolis Center for Health Policy publish a summary of a 2019 workshop they co-sponsored on improving the communication of drug inter...
Federal Register notice: FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device ...
Two professors of medicine and law suggest ways FDA can encourage companies to complete confirmatory trials of drugs reaching market through the accel...
FDA warns Chinas Hubei Kangzheng Pharmaceutical Company about CGMP violations and manufacturing unapproved new drugs.