U.S. flag An official website of the United States government

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
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of the Commissioner
  5. Office of the Chief Scientist
  6. Office of Specialty Laboratories and Enforcement Support
  1. Office of the Chief Scientist

Office of Specialty Laboratories and Enforcement Support Also referred to as: OSLES

Mission 

To improve global public health by providing rapid responsive solutions to scientific problems that improve regulatory and enforcement decision making.  

Vision 

To be global leaders in public health protection by amplifying our impact through strategic scientific, enforcement and regulatory collaborations.  
 

Functions 

  • Provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory and forensic science, addressing the quality, safety, and effectiveness of Food and Drug Administration (FDA) regulated products.  
  • Advises the Office of the Chief Scientist (OCS) on regulatory and forensic scientific issues related to all FDA regulated products including pharmaceuticals, foods including radionuclides, medical products including biological and microbiological safety of medical devices, electronic product radiation, and tobacco products.  
  • Operates satellite laboratories where scientists work side-by-side with investigators and agents to rapidly screen and analyze suspect imported parcels for unapproved, counterfeit, and illegal pharmaceuticals, including opioids, significantly expanding the effectiveness and safety of import operations at selected points of entry.  
  • Plans and conducts laboratory testing and fosters development and use of innovative technologies to meet current and emerging public health needs.  
  • Coordinates with FDA Centers and Offices on specialty laboratory scientific resources, including subject matter experts, to assure a cohesive, efficient, and effective approach to public health protection.  
  • Works with appropriate Centers and Offices to establish and execute strategic and tactical plans for the effective use of laboratory resources relative to medical products, foods, forensic testing, radiochemistry, and tobacco.  
  • Provides administrative functions for laboratory operations, including budget execution, travel, and human resources, in coordination with OCS. 
  • Collaborates with other Federal, State, and Local agencies to expand the nation’s capacity of biological, chemical, radiological, and nuclear emergency response. 
  • Collaborates with other Federal agencies to provide actionable intelligence, scientific support and research to the intelligence community. 
  • Collaborates with Centers and Offices to assist investigators during inspections and investigations relating to manufacturing facilities to evaluate compliance with appropriate standards, Current Good Manufacturing Practice Regulations, and other regulations and requirements. 
  • Provides scientific support for field operations and search warrants conducted by field investigators and special agents. Provides training in the operational aspects of medical products, radiation emitting and electronic product testing, radiological safety, automated drug analysis, and other related compliance program areas.  
  • Provides evaluation of field deployable tools and associated training and reach-back support to scientists, field investigators and agents in the safe operation and application of these instruments.

Resources 



Back to Top