Orphan Disease Natural History Grants Latest FDA Incentive For Drug Development
Agency will make $2m available in 2017.
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NIH plans to select two dozen groups to participate in a Global Rare Disease Patient Registry pilot project, which FDA hopes will lead to a better understanding of the conditions and speed drug development.
CDER Director Janet Woodcock says rare disease advocates should consider organizing patients to study a rare disease history and progression.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.