Atom | Rare Disease Endpoint Advancement (RDEA) Pilot Program

Due Dates: September 30, 2025 | December 31, 2025 | March 31, 2026 | June 30, 2026 (Quarterly through June 30, 2027)

Funding Amounts: Not a direct funding mechanism; selected proposals receive structured FDA engagement and up to four meetings to advance novel endpoint development.

Summary: Supports the development of novel efficacy endpoints for rare disease drugs through structured collaboration and guidance with the FDA.

Key Information: Program offers FDA feedback but does not guarantee regulatory approval or endpoint qualification.

Rare Disease Endpoint Advancement (RDEA) Pilot Program - FDA

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