No change in FDA approval time despite new technology, study shows


Even given implementation of information technology, FDA drug approval time has not decreased, according to researchers.

Despite increased use of information technology, FDA drug approval time is still not shorter, according to scientists.

Associate Professor John Kros and Assistant Professor Christopher Keller of East Carolina University, said FDA has implemented new information technology in an effort to reduce the time required between the submission of a new drug application, and final approval.

Although the 1992 Prescription Drug User Fee Act required drug companies to pay fees to the FDA in return for an agreement to set time limits on the review process for new drug applications, the scientists said their study found no statistically significant reduction in approval intervals from 1997 to 2006.“The present research contributes a baseline for future comparison by which any future reductions in approval times which … result from the implementation of information technology could be verified,” the researchers said.

Their findings appear in the International Journal of Electronic Healthcare.

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