Key Takeaways for the Medical Writer from FDA’s Public Meeting: Supporting the Future of Rare Disease Product Development

FDA’s public meeting on February 24th left no uncertainty as to the future direction of drug development in rare disease: Patient-centric approaches that incorporate patient and caregiver input at all levels to ensure that clinical trial endpoints are robust and meaningful; and Utilization of patient data (registries, cases, natural history, and real world evidence) to…

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