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Levels of Evidence: Cancer Genetics. Therefore governments and rare disease patient organisations such as EURORDIS advocate for economic incentives to encourage drug companies to develop and market medicines for rare disease treatment. Find out the latest news from the rare disease community! What is an orphan drug? Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information to support their designation request.
Orphan drug designation is a separate process from seeking approval or licensing. Drugs for rare diseases go through the same rigorous scientific review process as any other drug for approval or licensing. See the orphan drug designations and approvals database for more information. Sponsors may submit orphan drug designation requests one of three ways:.
Portal for submitting orphan drug designation requests.
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