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  • October 9, 2026
  • Last Update July 17, 2026 9:28 pm
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CDER/CBER Rare Disease Evidence Principles (RDEP)

CDER/CBER Rare Disease Evidence Principles (RDEP)

CDER and CBER propose a new regulatory process for the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need.

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