REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
1. Sabril REMS modified (June 21, 2016) to:
- modify the goals
- remove the Medication Guide and communication plan as elements of the REMS
- remove ETASU that require:
- each patient using the drug be enrolled in a registry
- modify ETASU that require:
- healthcare providers who prescribe the drug have particular training or experience, or are specially certified
- pharmacies, practitioners, or healthcare settings that dispense the drug are specially certified
- the drug be dispensed to patients with evidence or other documentation of safe-use conditions
- modify the implementation system
- modify the timetable of submission of assessments
2. Probuphine REMS revised (June 26, 2016) to correct a typographical error(s)
3. Entereg REMS revised (June 14, 2016) to change the application holder’s name or address.
Learn more about how to use the REMS@FDA website through this tutorial.