Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders

The authors would like to thank the participants who attended the “Developing Rare Disease Regulatory Strategy Under Current Global Statutes: A Stakeholder Discussion” meeting on March 28, 2018, for their contributions to the discussions captured in this paper. Medical writing coordination and oversight was provided by Johanna Simosky, PhD of Amicus Therapeutics. Administrative and coordinating support for the conference was provided by Gina Maldonado and colleagues from BioNJ. Support of this initiative was not feasible without Jayne Gershkowitz and John Crowley of Amicus Therapeutics, Inc