Get Tablets Factor Xa Inhibitor Rems - Fda

Filling out the Tablets Factor Xa Inhibitor REMS form is crucial for ensuring the safe use of in patients with nonvalvular atrial fibrillation. This guide provides clear, step-by-step instructions to help users complete the form accurately and efficiently.

Follow the steps to fill out the Tablets Factor Xa Inhibitor REMS form correctly.

1. Press the ‘Get Form’ button to obtain the form and open it in your selected platform.
2. Review the form's introductory section, which outlines the goal of the REMS program. Ensure you understand the significance of the risk evaluation regarding thrombotic events associated with discontinuing .
3. Navigate to the Communication Plan section. Here, you will provide relevant information regarding the distribution of letters to healthcare professionals, ensuring that all notified parties are documented.
4. Fill in the Timetable for Submission of Assessments section. This will require specific dates for assessment submissions to the FDA, ensuring compliance with the REMS requirements.
5. Complete the sections related to reporting adverse events. Input contact information for both Bristol-Myers Squibb and the FDA MedWatch program for feedback and reporting.
6. Review your entries for accuracy. Ensure that all provided information aligns with the requirements set forth in the REMS guidelines.
7. Once you have filled in all required sections, proceed to save your changes. You can choose to download, print, or share the form as necessary.

Complete the Tablets Factor Xa Inhibitor REMS form online today to ensure compliance and patient safety.