Fast track
Facilitate the development and expedite review of drugs intended to treat serious conditions and address an unmet medical need.
Regenerative Medicine Advanced Therapy
Speeds the review of cell therapies, human gene therapies, therapeutic tissue engineering products, and human cell and tissue products intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug has potential to address an unmet medical need.
fast track designation requests granted by CDER in 2019
151
of the 48 novel drugs approved by CDER in 2019, were under the accelerated approval pathway
9
Accelerated approval
Accelerates approval for drugs for serious conditions that fill an unmet medical need based on a surrogate or intermediate clinical endpoint.
breakthrough therapy designation requests granted by CDER in 2019
67
Breakthrough therapy
Shortens development and review time when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoint(s).
RMAT designation requests granted in 2019
16
of the 48 novel drugs approved by CDER in 2019 had priority review designation
28
Priority review
Shortens marketing application review time for a drug that treats a serious condition and demonstrates the potential to be a significant improvement in the safety or effectiveness in the treatment, diagnosis or prevention of a disease.
Fast track
Accelerated approval
Breakthrough therapy
Priority review
RMAT
Priority review
Breakthrough therapy
Accelerated approval
Fast track
RMAT
Fast track
Facilitate the development and expedite review of drugs intended to treat serious conditions and address an unmet medical need.
RMAT
Priority review
Breakthrough therapy
Accelerated approval
Fast track
Fast track
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fast track designation requests granted by CDER in 2019
151
fast track designation requests granted by CDER in 2019
151