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500 Series - FDA Requirements for Human Subjects Research and Data and Safety Monitoring

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500 - Research Involving Drugs, Biological, and Nutritional Products

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501 - Research Involving FDA Regulated Devices 

501 - Policy - Research Involving FDA Regulated Devices (Printer friendly version available)

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502 - Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles)

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Humanitarian Use Device FAQs

ForHumanitarian Use Device (HUD) FAQs please navigate to this page


503 - Data and Safety Monitoring 

503 - Policy - Data and Safety Monitoring (Printer friendly version available)

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