FDA Alignment Is a Starting Point, Not a Rare Disease Strategy for the European Market

T2Covered by 1 source · first reported by Fierce Biotech / Fierce Healthcare / MedCity / GEN at 26 Oct, 11:30 UTC

[Sponsored] For US biotech companies developing rare disease therapies, decisions about clinical evidence, patient populations and regulatory advice can have consequences in Europe long before a marketing application is submitted. The post FDA Alignment Is a Starting Point, Not a Rare Disease…

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Sources

• T2FDA Alignment Is a Starting Point, Not a Rare Disease Strategy for the European MarketFierce Biotech / Fierce Healthcare / MedCity / GEN26 Oct, 11:30