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The Promising Pathway Act 2.0 amends the Federal Food, Drug, and Cosmetic Act to establish a conditional approval pathway for drugs and biological products intended to treat rare, progressive, serious, or terminal diseases with substantial unmet medical need. Sponsors may seek conditional approval based on Phase 1 safety data and Phase 2 effectiveness evidence (or preliminary animal model data for pediatric rare diseases), with priority FDA review and eligibility for other special designations. The conditional approval is time-limited, subject to FDA withdrawal if safety concerns emerge or eligibility criteria are no longer met, and automatically expires if the drug is not brought to market within one year or if renewal is not sought.
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