FDA approval
After successful completion of the required pivotal Phase III studies that demonstrate efficacy, drug developers submit a New Drug Application (NDA) to the FDA. Standard review is approximately 12 months, though more rapid reviews are becoming more common through specific pathways developed by the FDA (https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review, accessed June 15, 2020). These are reserved for priority drugs that represent an advance in treatment, diagnosis, or disease prevention when compared to marketed products. This process was used in the approval of elexacaftor/tezacaftor/ivacaftor (Trikafta®).