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Patients should be monitored closely for bleeding while receiving systemic ketorolac, receiving concurrent myelosuppressive chemotherapy, corticosteroid therapy, or anticoagulant therapy, tobacco smoking patients, or in patients with alcoholism

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In the CY 2025 PFS proposed rule (89 FR 61596, 61872), we explained that we intended to provide further information regarding the process, including the application contents and specific requirements such as the deadline for submitting applications and all supplemental application information that would be required, through guidance