14 October 2019 - Researchers at drug maker Sanofi are calling on the US FDA to make its publication of patient experience data in review documentation more consistent after reviewing applications approved in the first full year after a requirement of the 21st Century Cures Act compelled the agency to do so.

Under Section 3001 of the 21st Century Cures Act, FDA is required to "publish a brief statement on any patient experience data or related information that was part of the application" for applications submitted after 16 June 2017.

In 2018, FDA's Center for Drug Evaluation and Research approved 59 novel drugs and biologics. Of those, 48 applications (81.4%) included a Sec. 3001 patient experience data table within the review documentation. Among the 11 products that did not include a patient experience data table, seven were submitted to FDA prior to the implementation date for Sec. 3001.

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