Risk Evaluation and Mitigation Strategies (REMS) SPL Resources

 

 

Instructions for Sending a Test REMS SPL Document to FDA

To initiate the process of submitting a REMS SPL test submission, send the following details to spl@fda.hhs.gov:

• Contact’s Name
• Contact’s Company Name
• Contact’s Phone Number
• Contact’s Email Address
• Planned Date of Official Submission

REMS SPL test submissions should be submitted through the Test Electronic Submissions Gateway "OC" "center".

 

REMS SPL Sample