Regulatory & Documentation
Accelerated Approval
Accelerated Approval is an FDA pathway that allows earlier approval of drugs treating serious conditions and filling unmet medical need on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, conditional on confirmatory post-marketing trials.
Established in 1992 (codified at 21 CFR 314 Subpart H and 601 Subpart E), Accelerated Approval has been used extensively in oncology, HIV, and rare disease. The 2022 FDORA legislation tightened requirements, including expedited withdrawal authority when confirmatory trials fail or are not conducted.
EMA's parallel Conditional Marketing Authorisation pathway operates on similar principles. Both require sponsor commitments to specific post-approval studies (PMRs) with defined timelines.
References
Related terms
Surrogate Endpoint
A surrogate endpoint is a biomarker or intermediate clinical measurement used as a substitute for a direct measure of how a patient feels, functions, or survives, that is reasonably likely to predict clinical benefit.
IND Application (Investigational New Drug)
An Investigational New Drug (IND) application is the submission a sponsor files with the FDA to obtain authorization to ship an unapproved drug across state lines and to administer it to humans in a clinical trial.
Real-World Evidence (RWE)
Real-World Evidence (RWE) is clinical evidence about the use, safety, and effectiveness of a medical product derived from analysis of Real-World Data (RWD); EHRs, claims, registries, wearables; collected outside the controlled environment of a randomized clinical trial.
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