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
Enhanced Communication Team
Developed as part of the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V)
PDUFA V promotes innovation through enhanced communication between FDA and sponsors during drug development
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The FDA Enhanced Communication Team supports timely interactive communication with sponsors during drug development
This facilitates efficient and effective drug development programs, and enhances public health by making new and effective drugs available in a timely manner