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Breakthrough Fast Track Priority Accelerated Approval
4 Mar 2024

Write differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval

There is differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval. Here is a quick comparison of the USFDA drug development expedited programs. This may help you to distinguishing all of them effectively. 

Designation Purpose Criteria Regulatory Benefit
Breakthrough Therapy Expedite development and review of promising therapies Evidence indicating substantial improvement over existing options Intensive guidance from FDA, rolling review
Fast Track Facilitate development and expedite review Address unmet medical needs More frequent communication, rolling review
Priority Review Accelerate review of drugs for serious conditions Significant improvement compared to available therapies Accelerated FDA review timeline
Accelerated Approval Expedite approval of drugs for serious conditions Surrogate endpoints or intermediate clinical endpoints Conditional approval based on surrogate endpoint

These designations are all mechanisms provided by regulatory agencies, particularly the U.S. Food and Drug Administration (FDA), to expedite the development and review of drugs for serious conditions with unmet medical needs. Each designation has specific criteria and regulatory benefits tailored to facilitate the drug development process and bring important therapies to patients more quickly.

Breakthrough Fast Track Priority Accelerated Approval

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