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.
From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Rachel E
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Sherman
Jun
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Li
Stephanie
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Shapley
Melissa
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Robb
Janet
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Woodcock
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D006801:Humans; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational