Douglas Crandell

Douglas Crandell

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FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

3/27/2025  /  Clinical Trials , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Research , New Guidance , Pharmaceutical Industry , Regulatory Requirements , Research and Development
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