Verify Regulations
Some REMS-related functions and vendors are FDA regulated and some are not. As a vendor, know your status, and be prepared to explain what regulations apply (and don't apply) to the services you are performing or products you are supplying. Regulated REMS functions are those related to:
- Assessments of the REMS strategy
- Medication guide or patient package insert
- Communication plan to health care providers
- Elements to assure safe use (EASU)
- Software used to implement regulated REMS functions
If a service that the vendor performs (for example: program management) is not a regulated REMS function, it is not necessary for that vendor to comply with any particular regulations unless specified contractually.
