1. Application – standard 10-month review (unless expedited by a fast track/priority review designation) for efficacy, effectiveness, and safety.
2. Approval – FDA grants accelerated approval (prior to confirmatory trial) with specified timeline for required confirmatory trial(s) and post-market surveillance.
3. Post-accelerated approval – confirmatory studies conducted. From here, the FDA can convert the accelerated approval to a full, traditional approval if the drug confirms clinical benefit. If no clinical benefit is shown, the FDA has the regulatory authority to remove the drug from the market.