Breakthrough Fast Track Priority Accelerated Approval

4 Mar 2024

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

Posted Byroysr

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TagsAccelerated Approval, Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation

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