Momentum Life Sciences
REMS
Spravato
CC Operations
General Terminology
100

This platform is where you can find your training guides, process documents, and program resources — all in one searchable place.

What is Guru? 
100

REMS stands for this FDA safety program designed to ensure that the benefits of a drug outweigh its risks.

What is Risk Evaluation and Mitigation Strategy?

100

This is the primary indication for which Spravato is FDA-approved. 

What is treatment-resistant depression (TRD)?

100

This is the abbreviation for Patient Monitoring Form. 

What is PMF?

100

The FDA is short for this U.S. government agency.  

What is: Food and Drug Administration?

200

If you have a question during training, you can post it here to get help from your trainer or peers.

What is the Training Teams chat?

200

These documents, often part of a REMS, provide FDA-approved patient-friendly drug safety information and must be distributed with certain prescriptions

What are Medication Guides?

200

Spravato is administered using this route of administration.

What is intranasal? 

200

This directs calls to the correct queue and provides the required Call Recording Statement. 

What is Interactive Voice Response (IVR)?
200

This is a digital version of a patient's medical history, maintained by healthcare providers over time. 

What is an electronic health record (EHR)? 

300

Another name for the Momentum Homepage. 

What is SharePoint? 

300

REMS programs often require ongoing data collection and periodic review of their effectiveness. This is called a(n) ___.

What is an Assessment Plan?

300

Because of risks such as sedation, dissociation, and increased blood pressure, patients must be monitored for at least this long after each dose.

What is two hours?

300

This case outcome is chosen when an objective is met, and no further action is needed. 

What is Completed-Resolved?

300

This is a program designed to help eligible patients access medication at low or no cost if they cannot afford it. 

What is Patient Assistance Program (PAP)? 
400
Passionate about empowering people, sharing our gifts, and celebrate life and work are all examples of this. 

What are core values?

400

These specific safety requirements may be mandated as part of a REMS, such as training, certification, or restricted dispensing. 

What are Elements to Assure Safe Use (ETASU)?

400

Spravato treatment is only available at certified treatment centers through this FDA-required safety program.

What is the REMS (Risk Evaluation and Mitigation Strategy) program?

400

This is an unsolicited inquiry seeking scientific or clinical information about Spravato, typically from healthcare professionals or patients. 

What is Medical Information Request (MIR)? 

400

This is a reimbursement model where healthcare providers purchase a drug directly and then bill the payer after administering it to the patient. 

What is buy & bill?

500

This is our mission at Momentum. 

What is streamlining the patient experience? 
500

The FDA’s authority to require a REMS comes from this 2007 law that amended the Federal Food, Drug, and Cosmetic Act.

What is the FDA Amendments Act (FDAAA)?

500

This is the generic name for Spravato. 

What is esketamine? 

500
These are the three data points needed for required verification information. 

What is patient's first name, last name, and DOB? 

500

The abbreviation PV in pharmaceuticals stands for this practice of monitoring drug safety.

What is pharmacovigilance?