Editorial: The use of real world data for regulatory purposes in the rare diseases setting
- PMID: 36506540
- PMCID: PMC9730868
- DOI: 10.3389/fphar.2022.1089033
Editorial: The use of real world data for regulatory purposes in the rare diseases setting
Keywords: medicine regulation; orphan medicines; rare diseases; real world data; real world evidence.
Conflict of interest statement
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Comment on
- Editorial on the Research Topic The use of real world data for regulatory purposes in the rare diseases setting
References
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- EU Digital Strategy eHealth (2022). Shaping Europe’s digital future. Available at: https://digital-strategy.ec.europa.eu/en/policies/ehealth (Accessed on October 26, 2022).
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- European Commission, Directorate-General for Research and Innovation (2021). Study on the use of real-world data (RWD) for research, clinical care, regulatory decision-making, health technology assessment, and policymaking; Final report and recommendations. Brussels: Publications Office of the European Commission. Available at: https://data.europa.eu/doi/10.2777/340449 . - DOI
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- European Medicines Agency (2022). Qualification of novel methodologies for medicine development. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/scien... (Accessed September 25, 2022). - PubMed
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