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Sixth, while the FAERS database provides valuable insights, exclusion of international pharmacovigilance databases such as the EudraVigilance or WHO VigiBase limits global generalizability, though accessibility constraints justify this approach

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Additionally, we are finalizing, with modifications, our proposed amendments to 180.50 to require hospitals to attest that in the MRF, to the best of the hospital's knowledge and belief, the hospital has included all applicable standard charge information in accordance with the requirements of this section and the information encoded is true, accurate, and complete as of the date in the file

This is a softer, safer approach with fewer side effects