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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  3. FDA Organization
  4. Office of the Commissioner
  5. Office of the Chief Scientist
  6. Office of Analytical and Regulatory Laboratories
  1. Office of the Chief Scientist

Office of Analytical and Regulatory Laboratories Also referred to as: OARL

Vision 

To be a leader in advancing regulatory science and public health protection through innovative laboratory testing, strategic collaboration, and expert guidance on FDA-regulated medical and tobacco products, ensuring quality, safety, and efficacy. 

Mission 

To provide expert scientific leadership and timely analytical support to the FDA medical products centers and Center for Tobacco Products by advancing regulatory science through high-quality and collaborative laboratory activities, ensuring that regulated products are safe, effective, and comply with laws, regulations, and policies. 

Functions 

  • Advises the Office of the Chief Scientist (OCS) on scientific issues and laboratory activities related to tobacco, pharmaceuticals, and nanotechnology. 
  • Provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning the Food and Drug Administration (FDA) regulated products, including their evaluation, quality, safety, and effectiveness.  
  • Plans and conducts the development and use of innovative technologies to meet public health needs.  
  • Foster strategic collaboration with FDA Centers and Offices on analytical regulatory laboratory scientific resources, including subject matter experts, to assure a cohesive, efficient, and effective approach to public health protection.  
  • Plans and conducts scientific research and regulatory testing at the Detroit Medical Products Laboratory, Irvine Medical Products Laboratory, New York Medical Products Laboratory, San Juan Medical Products Laboratory, and the Tobacco Products Laboratory.    
  • Supports medical product inspectional activities by providing subject matter experts with knowledge of environmental sample collection and Current Good Manufacturing Practices related to laboratory methods, environmental monitoring, audit trails, and analytical instrumentation qualification and operation.  
  • Provide specialized technical training and professional development programs that enhance scientific expertise, promote innovation, and maintain the ongoing technical competency of laboratory personnel.   
  • Implement and maintain comprehensive quality management systems that ensure laboratory data integrity, accuracy, and compliance with quality standards.  

Internship and Volunteer Opportunities 

We offer opportunities to for internships through partnerships with academia and volunteer programs: 



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