Footnotes

• Contributors All authors contributed to the intellectual content and preparation of the manuscript, and approved the final version of the manuscript.

• Funding This analysis was made possible through support from the Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI), a cooperative agreement (U01FD004319) funded by the US Food and Drug Administration (FDA). The support for DG’s Fellowship in Regulatory Science was provided by the Pharmaceutical Research and Manufacturers of America (PhRMA). Neither the US Food and Drug Administration nor the Pharmaceutical Research and Manufacturers of America had a role in and preparation or approval of the manuscript. Its content is solely the responsibility of the authors and does not necessarily represent the official views of sponsors or institutions with which the authors are affiliated.

• Competing interests None declared.

• Patient consent Not required.

• Provenance and peer review Not commissioned; internally peer reviewed.