The FDA’s Accelerated Approval Program provides a path for earlier approval of drugs being developed to treat serious diseases and address unmet medical need. The process allows the use of a surrogate endpoint—an indirect marker of clinical benefit that allows the drug to be approved and in the hands of patients earlier, while the company continues to conduct post-marketing “confirmatory trials” to establish the drug’s benefits. It is important to understand that the FDA has processes in place to remove the drug from the market in case clinical benefit is not established with confirmatory trials.
