Podcast
Play an AI-generated podcast conversation about this lesson
Download our mobile app to listen on the go
Get App
Questions and Answers
What is the review time for Priority Review by the FDA?
What is the review time for Priority Review by the FDA?
- 12 months
- 3 months
- 6 months (correct)
- 10 months
The Fast Track designation is for drugs that do not fill an unsatisfied medical need.
The Fast Track designation is for drugs that do not fill an unsatisfied medical need.
False (B)
What is required for a drug to qualify as a Breakthrough Therapy?
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.
The FDA will approve drugs based on significant improvement of a surrogate or intermediate endpoint in _____ Approval.
Signup and view all the answers
Flashcards are hidden until you start studying
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
