…nition B. Exceptions 1. Infeasibility a. Infeasibility Exception—Uncontrollable Events Condition b. Third Party Seeking Modification Use c. Manner Exception Exhausted 2. Manner Exception—TEFCA Reasonable and Necessary Activities a. Background b. TEFCA Condition for the “Manner” E…

…Additional Supply of Medication (Resupply) xii. Communicate Drug Administration Events (DrugAdministration) xiii. Request and Respond to Transfer One or More Prescriptions Between Pharmacies (RxTransferRequest, RxTransferResponse, RxTransferConfirm) xiv. Recertify the Continued A…

… instead interquartile ranges ( 90 FR 18099 ). The applicant summarized adverse events reported in Cauchy et al. (2011) and Crooks et al. (2022), as well as a multicenter retrospective cohort study and the AURLUMYN TM prescribing information. The applicant also referenced the NDA…