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FDA special designa.
FDA Special Designation
| Question | Answer |
|---|---|
| Orphan Designation is a designation given to a drug or biological product to ______, _____, or _____ a rare disease or condition. Drugs approved may be eligible for up to ___ years of market exclusivity after approval | prevent, diagnose, treat |
| Breakthrough Therapy--> a process designed to expedite the development and review of drugs that are intended to ____ a serious condition and preliminary clinical evidence indicates that that the drug may demonstrate ____ _____ over available therapy on a clinically sig. _____ | treat; substantial improvement; endpoints |
| Accelerated Approval--> Regulations that allow drugs for serious conditions that fill an ___ ____ _____ to be approved based on ____ ____ | unmet medical need; surrogate |
| Fast Track--> A process designed to facilitate the development of an _____ the review of drugs to treat serious conditions and fill an ____ ____ ____ | expedited; unmet medical need |
| Priority review--> FDA's goal is to take action on an application w/in __ months (compared to __ months under standard review) | 6; 10 |
| A priority review designation will direct overall _____ and _____ to the evaluation of applications for drugs that would be significant improvements in the ____ and _____ of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications | attention; resources; safety; effectiveness |
Created by:
Xander635