The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 29209711.
- Also identified by DOI 10.1001/jama.2017.14896 and PMC identifier 5820715.
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Abstract
This study uses the Drugs@FDA database to analyze clinical development times for drugs to treat serious diseases within the 4 FDA expedited programs intended to speed drug review and approval.
Medical subject headings
- Drug Approval
- United States Food and Drug Administration