The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016 image

JAMA, Issue 318, no. 21
Thomas J. Hwang, Jonathan J. Darrow (Student Fellow Alumnus), Aaron S. Kesselheim


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From the paper:

The US Food and Drug Administration (FDA) has 4 expedited programs to speed the development and review of drugs treating serious diseases: (1) priority review leads to FDA review in 6 months (vs 10 months for standard review); (2) accelerated approval permits approval based on surrogate measures; and (3) fast-track and (4) breakthrough therapy programs are intended to reduce the duration of clinical trials (Table).1 Clinical development times for drugs in these expedited programs, particularly the newly created breakthrough program (enacted in 2012), have not been comprehensively assessed. We analyzed clinical development times within each of the 4 expedited programs separately and between drugs qualifying for any vs no expedited program. Because fast-track and breakthrough programs are intended to abbreviate the overall drug development process, we also examined development times for drugs receiving either or both of these 2 programs (regardless of other programs).

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