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Questions and Answers
What is the review time for Priority Review by the FDA?
The Fast Track designation is for drugs that do not fill an unsatisfied medical need.
False
What is required for a drug to qualify as a Breakthrough Therapy?
Preliminary evidence shows significant improvement compared to approved treatment options
The FDA will approve drugs based on significant improvement of a surrogate or intermediate endpoint in _____ Approval.
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Study Notes
Priority Review
- Drug applications are reviewed within 6 months, compared to the standard 10 months.
Fast Track
- Aims to expedite the review process for drugs that address unmet medical needs in serious conditions.
Breakthrough Therapy
- Designed for drugs with preliminary clinical evidence demonstrating substantial improvement over existing treatments for serious or life-threatening conditions.
Accelerated Approval
- Permits early approval of drugs based on clinical data demonstrating significant improvement in a surrogate or intermediate endpoint, which is a marker that is not necessarily a direct measure of clinical benefit.
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Description
This quiz covers the key processes involved in drug approval, including Priority Review, Fast Track, Breakthrough Therapy, and Accelerated Approval. Each section aims to clarify how these processes expedite access to treatments for serious conditions. Test your knowledge on these essential concepts in drug regulation.
