US drug approvals lower than previously reported; new study

10 January 2014

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration approval from late 2003 to the end of 2011 is near one in 10, according to a new study.

These findings, from a peer-reviewed paper co-authored by the Biotechnology Industry Organization (BIO) Industry Analysis and BioMedTracker (BMT), appeared in Nature Biotechnology on January 9. The findings contrast previous reports, taken from earlier years, which showed the rate of drug approvals is one in five to one in six.

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