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- EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategyThe European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
- FDA unveils new rare disease framework to streamline evidence standards and speed therapiesThe FDA announced a new Rare Disease Framework Initiative aimed at standardizing how scientific evidence is evaluated for rare disease therapies. The framework seeks to apply consistent clinical t…