Expediting drug development--the FDA's new "breakthrough therapy" designation.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 24224621.
- Also identified by DOI 10.1056/NEJMp1311439.
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Abstract
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.
Medical subject headings
- Drug Approval
- Drugs, Investigational