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U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Engaging with the FDA During New Drug Development
Paths of Contact to Engage with FDA
Office of New Drugs Rare Diseases Program
Program Mission:
To facilitate, support, and accelerate the development of drug and biologic products for the benefit of patients with rare disorders
Program Activities
Coordinates the development of CDER policy, procedures, and training for the review of treatments for rare diseases
Assists in outside development and maintenance of good science as the basis for the development of treatments for rare diseases
Works collaboratively with external and internal rare disease stakeholders
Serves as CDER's focal point to the rare disease drug development community on how best to interact with CDER
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