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Registration is now open to attend the FDA Rare Disease Innovation Hub’s March 30th Rare Disease Innovation, Science, and Exploration (RISE) Workshop to explore data sharing as it pertains to informing development and regulatory review for rare disease therapies.
This public workshop will focus on clarifying possible avenues for data sharing and the types of data that can be shared (e.g., safety information, real-world evidence, and deidentified patient data).The workshop will also discuss: the promotion of data sharing practices and structures for facilitating data sharing among rare disease drug development stakeholders; examples of the impact of data sharing in regulatory submissions; a priori considerations for the collection and sharing of high quality data; some of the logistical and legal challenges encountered in data sharing; and whether there are ways that FDA might support data sharing, within the bounds of its authority.
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