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Novedades regulatorias de FDA, EMA, TGA y organismos globales

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Actualizaciones regulatorias
9 sept 2026•1 min de lectura
Korea MFDS Expands GIFT Review to Include Patient Experience Data
The Korean MFDS revised its GIFT fast‑track guidelines, permitting patient‑reported symptoms, quality‑of‑life data, preferences, interviews, videos and written opinions as reference material for priority review of rare disease drugs.