Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders
Open Access
- 6 June 2021
- journal article
- research article
- Published by Springer Science and Business Media LLC in Drug Safety
- Vol. 44 (8), 853-861
- https://doi.org/10.1007/s40264-021-01081-z
Abstract
In rare diseases, registry-based studies can be used to provide natural history data pre-approval and complement drug efficacy and/or safety knowledge post-approval.This publication has 16 references indexed in Scilit:
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