Breakthrough-Therapy Designation — An FDA Perspective
نویسندگان
چکیده
منابع مشابه
Expediting drug development--the FDA's new "breakthrough therapy" designation.
The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.
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Recent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated Approval and Breakthrough Therapy Designation hold the promise of making new treatments availa...
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ژورنال
عنوان ژورنال: New England Journal of Medicine
سال: 2018
ISSN: 0028-4793,1533-4406
DOI: 10.1056/nejmc1801222