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U.S. Department of Health and Human Services

About FDA

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Office of Scientific Investigations

 
The goals of OSI are to:
  • To verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications.
  • To assure that the rights and welfare of human research subjects are protected.
     
OSI Accomplishes this by:
  • Auditing and verifying clinical trial data submitted to the FDA in support of applications to demonstrate the safety and efficacy, or bioequivalence, of drugs for human use; 
  • Directing inspections of Institutional Review Boards (IRBs) for compliance with standards and regulations designed to protect the rights and welfare of human research subjects; and 
  • Ensuring that investigators, sponsors, and contract research organizations who conduct nonclinical and clinical studies on investigational new drugs comply with United States laws and regulations covering good clinical practice and good laboratory practice.
   

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