EMA And FDA Eliminating ‘Needless Differences’ – Particularly For Rare Diseases

US and EU regulators have invited two companies to work with them on a pilot scheme for assessing drugs for rare genetic diseases, a move that the European Medicines Agency’s Emer Cooke said would help improve “global alignment.”

Francesca Buttigieg, Anthonius de Boer, Steffen Thirstrup and Sabine Haubenreisser at the TOPRA Symposium 2024
Francesca Buttigieg, Anthonius de Boer, Steffen Thirstrup and Sabine Haubenreisser at the TOPRA Symposium 2024 • Source: Pink Sheet

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