Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases
Funds clinical trials testing whether a product works and is safe for a rare disease, aimed at a new indication or a labeling change.
Most rare diseases have no approved treatment, and the ones that do often got there through a small, hard-won trial rather than a large one. This notice funds that trial.
The money supports clinical trials evaluating a product's efficacy and safety in support of a new indication or a labeling change for a rare disease or condition. FDA names the goal directly: more approved treatments for rare di…
Clinical trials evaluating the efficacy and/or safety of a product for a rare disease or condition, in support of a new indication or a labeling change, favouring collaborative, efficient or innovative trial designs. A clinical trial is required under this activity code.
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