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- FDA proposes new framework prioritizing consistency over flexibility for rare disease drug reviewsThe FDA announced a shift in its approach to evaluating rare disease therapies, emphasizing a more uniform assessment process. Agency officials explained that the flexibility shown over the summer…
- FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populationsThe FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…