Priority review
Priority review
Priority review is a designation given by the Food and Drug Administration (FDA) to a drug that, if approved, would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition. This designation is intended to direct overall attention and resources to the evaluation of such applications.
Pronunciation
- Pronunciation: /praɪˈɔːrɪti rɪˈvjuː/
Etymology
The term "priority review" is derived from the English words "priority", meaning precedence in order or importance, and "review", meaning a formal assessment or examination.
Related Terms
- Fast Track (FDA): A process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
- Breakthrough Therapy: A process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
- Accelerated Approval: FDA may approve a drug for a serious condition that fills an unmet medical need based on a surrogate endpoint.
- Orphan Drug: A special status given to a drug or biological product (a “drug”) to treat a rare disease or condition upon request of a sponsor.
External links
- Medical encyclopedia article on Priority review
- Wikipedia's article - Priority review
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