1. CDER E2B(R2) Combination Product Best Practices
  2. FAQ
  3. Is MAH required to report cases that contain combination products that include a non-company product as PMOA?

Is MAH required to report cases that contain combination products that include a non-company product as PMOA?

MAH is not required to report cases that contain combination products that include a non-company product as PMOA to the FDA.

Parent topic: FAQ