MIUDELLA - Sebela Women's Health Inc.

Sebela Women's Health Inc. must provide training to healthcare providers who dispense MIUDELLA for insertion.

The training includes the following educational materials: Prescribing Information including Instructions for Use, Insertion Training Program for Healthcare Providers, and Healthcare Provider Knowledge Assessment. The training must be available online and by calling the REMS.

Sebela Women's Health Inc. must provide training to pharmacies and healthcare settings that dispense MIUDELLA .

The training includes the following educational materials: Pharmacy Guide and Healthcare Setting Guide. The training must be available online and by calling the REMS.

To support the REMS operations, Sebela Women's Health Inc. must:

1. 1.Establish and maintain a REMS Website, MIUDELLAREMS.com. The REMS Website must include the capability to complete healthcare provider, pharmacy, and healthcare setting enrollment online, complete the Insertion Training Program for Healthcare Providers and Healthcare Provider Knowledge Assessment online, and have option to print the Prescribing Information and REMS materials (excluding the Insertion Training Program for Healthcare Providers). All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website.
2. 2.Make the REMS Website fully operational, and all REMS materials available through the REMS Website or coordinating center at the time MIUDELLA first becomes commercially available.
3. 3.Establish and maintain a coordinating center for REMS participants at (1-855-337-0772).
4. 4.Establish and maintain a validated, secure database of all REMS participants who are certified in the MIUDELLA REMS.
5. 5.Ensure healthcare providers who dispense MIUDELLA for insertion are able to enroll by submitting a completed Healthcare Provider Enrollment Form online and by fax.
6. 6.Ensure healthcare providers who dispense MIUDELLA for insertion are able to re-certify by reviewing the Insertion Training Program for Healthcare Providers and successfully completing the Healthcare Provider Knowledge Assessment after any two-year period of inactivity for inserting MIUDELLA.
7. 7.Ensure pharmacies are able to enroll by submitting a completed Pharmacy Enrollment Form online and by fax.
8. 8.Ensure healthcare settings are able to enroll by submitting a completed Healthcare Setting Enrollment Form online and by fax.
9. 9.Provide the Healthcare Provider Enrollment Form, Insertion Training Program for Healthcare Providers, and Healthcare Provider Knowledge Assessment to healthcare providers who (1) attempt to order MIUDELLA and are not yet certified or (2) inquire about how to become certified.
10. 10.Provide the Pharmacy Enrollment Form and Pharmacy Guide to pharmacies that (1) receive their first MIUDELLA prescription and are not yet certified or (2) inquire about how to become certified.
11. 11.Provide the Healthcare Setting Enrollment Form and Healthcare Setting Guide to healthcare settings that (1) receive their first MIUDELLA prescription and are not yet certified or (2) inquire about how to become certified.
12. 12.Provide certified healthcare providers access to the database of certified pharmacies and healthcare settings.
13. 13.Provide certified pharmacies and healthcare settings access to the database of certified healthcare providers and healthcare settings.
14. 14.Provide authorized wholesalers-distributors access to database of certified pharmacies and healthcare settings.
15. 15.Confirm the healthcare setting has one or more healthcare providers certified to dispense MIUDELLA for insertion affiliated with the address before certifying the healthcare setting.
16. 16.Notify healthcare providers who dispense MIUDELLA for insertion, and pharmacies and healthcare settings that dispense MIUDELLA within 2 business days after they become certified in the REMS program.

To ensure REMS participants' compliance with the REMS, Sebela Women's Health Inc. must:

1. 17. Verify annually that the authorized representative's name and contact information correspond to those of the current designated authorized representative for the healthcare setting and that all processes and procedures are in place and followed. If different, the healthcare setting must be required to re-certify with a new authorized representative.
2. 18.Maintain adequate records to demonstrate that the REMS requirements have been met, including but not limited to records of: MIUDELLA distribution, certification of healthcare providers who dispense MIUDELLA for insertion, certification of pharmacies, certification of healthcare settings including records that all healthcare settings have at least one certified healthcare provider affiliated with their address, authorization of wholesalers-distributors; and audits of the REMS participants. These records must be readily available for FDA inspections.
3. 19.Establish and maintain a plan for addressing non-compliance with REMS requirements.
4. 20.Monitor healthcare providers who dispense MIUDELLA for insertion, pharmacies and healthcare settings, and wholesaler-distributors on an ongoing basis to ensure the REMS requirements are being met. Take corrective action if non-compliance is identified, including de-certification.
5. 21.Audit all pharmacies (100%) within 180 calendar days after receipt of first shipment of MIUDELLA to ensure that REMS processes and procedures are in place, functioning, and support the REMS requirements. Audit all pharmacies (100%) annually to ensure that REMS processes and procedures are in place, functioning, and support the REMS requirements.
6. 22.Audit a randomized, representative sample (sample size should be calculated based on the following criteria: assume the true rate of compliance is 95% and aim to rule out compliance below a 90% threshold with a power level of 80%) of healthcare settings within 180 calendar days after receipt of first shipment of MIUDELLA to ensure that REMS processes and procedures are in place, functioning, and support the REMS requirements. Audit a randomized, representative sample (sample size should be calculated based on the following criteria: assume the true rate of compliance is 95% and aim to rule out compliance below a 90% threshold with a power of 80%) of healthcare settings annually to ensure that REMS processes and procedures are in place, functioning, and support the REMS requirements.
7. 23.Audit all wholesaler-distributors within 180 calendar days after they become authorized and audit all wholesaler-distributors annually to ensure that MIUDELLA REMS processes and procedures are in place, functioning, and support the REMS requirements.
8. 24.Take reasonable steps to improve the operations of and compliance with the MIUDELLA REMS requirements based on monitoring and evaluation of the MIUDELLA REMS.

Sebela Women's Health Inc. must submit REMS Assessments at 6 months and 18 months from the date of the initial REMS approval (02/24/2025), and every 12 months thereafter from the due date of the 18- month submission. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Sebela Women's Health Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

Healthcare provider who dispenses MIUDELLA for insertion:

1. 1.Healthcare Provider Enrollment Form

Pharmacy:

1. 2.Pharmacy Enrollment Form

Healthcare setting:

1. 3.Healthcare Setting Enrollment Form

Healthcare provider who dispenses MIUDELLA for insertion:

1. 4.Insertion Training Program for Healthcare Providers
2. 5.Healthcare Provider Knowledge Assessment

Pharmacy:

1. 6.Pharmacy Guide

Healthcare setting:

1. 7.Healthcare Setting Guide

1. 8.REMS Website