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Federal Register notice: FDA issues a final rule to amend the medical device regulations on procedures for announcing approvals an...[ Price : $8.95]
FDA clears an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology, a new cardiac mapping platform designed to ...[ Price : $8.95]
FDA releases an FDA-483 with seven observations from an inspection at Longview, TX-based Med Shop Total Care.[ Price : $8.95]
Federal Register notice: FDA corrects a notice in the 11/1/2021 Federal Register that announced the regulatory review period for D...[ Price : $8.95]
FDA warns against using unapproved LuSys Laboratories Covid-19 tests due to a potentially high risk of false results.[ Price : $8.95]
FDA and the Duke-Margolis Center for Health Policy publish a summary of a 2019 workshop they co-sponsored on improving the communi...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufa...[ Price : $8.95]
Two professors of medicine and law suggest ways FDA can encourage companies to complete confirmatory trials of drugs reaching mark...