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FDA clears a Cardio Flow510(k) for the companys FreedomFlow Orbital Atherectomy Peripheral Platform.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devic...[ Price : $8.95]
Federal Register notice: FDA withdraws two guidances Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing...[ Price : $8.95]
FDA warns Denver, CO-based Hygienic Labs that it has not responded to multiple requests for records and information so the agency ...[ Price : $8.95]
Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with ...[ Price : $8.95]
FDA posts a revised guidance entitled Development and Licensure of Vaccines to Prevent Covid-19.[ Price : $8.95]
Nine FDAers discuss the agencys use of real-world data and real-world evidence, and the confusion that exists on those terms and h...[ Price : $8.95]
FDA publishes a guidance on CBERs voluntary consensus standards recognition program for regenerative therapy products.