A regulatory pathway designed to expedite the development and approval of drugs for serious conditions, typically those with an unmet medical need. It allows for earlier approval based on surrogate or intermediate endpoints that are reasonably likely to predict clinical benefit.
A substitute measurement used in clinical trials that may not directly measure clinical benefit but is expected to reflect a meaningful outcome. Accelerated Approval often relies on surrogate endpoints to speed up the assessment process.
Refers to a condition where existing treatments are inadequate, and there is a significant gap in addressing the medical needs of patients. Accelerated Approval aims to provide quicker access to drugs for such conditions.
The positive effect of a medical intervention on a patient’s health is demonstrated through improvements in symptoms, survival, or overall quality of life. Accelerated Approval seeks to predict and grant approval based on clinical benefit, even if long-term data is not yet available.
Specific studies or actions are required by regulatory authorities after Accelerated Approval to gather additional information about a drug’s safety and efficacy. These commitments ensure ongoing evaluation and monitoring post-approval.
An expedited review process is granted by regulatory agencies for drugs addressing serious conditions, aiming to facilitate development and expedite the review timeline. It often precedes Accelerated Approval.
Studies conducted after a drug has been approved to gather additional information on its safety, efficacy, and optimal use in real-world settings. Accelerated Approval often involves a commitment to conducting Phase 4 trials.
An expedited review is granted to drugs that offer significant advancements in treatment or address unmet medical needs. Accelerated Approval is often associated with Priority Review to speed up the evaluation process.
Safety measures are implemented by the drug manufacturer to ensure the benefits of a drug outweigh its risks. REMS may include additional monitoring, education programs, or restricted distribution.
Data obtained from sources outside traditional clinical trials, such as electronic health records and patient registries, are used to assess a drug’s effectiveness and safety in real-world settings. Accelerated Approval may leverage RWE for ongoing evaluation.
The process of confirming that a surrogate endpoint reliably predicts clinical benefit. As post-approval data becomes available, validating surrogate endpoints is crucial for confirming the drug’s efficacy and maintaining its approval status.
An approval status is granted based on incomplete clinical trial data, with the condition that the drug manufacturer continues to provide additional data post-approval to confirm its efficacy and safety. This is often associated with Accelerated Approval pathways.