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FDA prescribing information and clinical practice guidelines emphasize lifestyle modifications and proper medication management as primary strategies for minimizing digestive side effects

These FAQs arrive on the tail of OIGs March 10, 2023 COVID-19 Public Health Emergency policy statement, which announced that the expiration of the PHE in May also marks the end of flexibilities extended during the crisis

Prescribing an unapproved new drug outside a trial is technically illegal under the FDCA (aside from narrow compassionate-use exceptions)

Statements Author contributions KS and LB conceptualized the work and wrote the first draft of the manuscript