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level: Level 4

Questions and Answers List

Question	Answer
Can the Approval Process be shortened? What are the ways?	1 Fast Track 2 Breakthrough Therapy 3 Priority Review 4 Accelerated Approval FBPAge
A process designed to HELP SHORTEN THE TIME it takes to develop and review drugs that treat serious condition and FILL AN UNMET MEDICAL NEED.	Fast Track
The FDA can speed up the development and review of a drug if the EVIDENCE FROM EARLY CLINICAL TRIALS shows that it is a SUBSTANTIAL IMPROVEMENT compared with other available treatments.	Breakthrough Therapy
The FDA will aim to take action on an NDA within 6 months (compared with 10 months under standard review)	Priority Review
FDA regulation that allows EARLY APPROVAL for drugs that treat serious conditions or address an unmet medical need. Approval may be granted BASED ON A SURROGATE ENDPOINT.	Accelerated Approval