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                Science & Research (Food)

Science & Research (Food)

                        


                        CFSAN Risk & Safety Assessments
          CFSAN Social and Behavioral Research
          Chemistry Research (Food)
          Data Science (Food)
          Laboratory Methods (Food)
          Microbiology Research (Food)
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          Science & Research (Food)
          CFSAN Bioresearch Monitoring ProgramScience & Research (Food) CFSAN Bioresearch Monitoring Program
  
  	
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    PrintThe Food and Drug Administration's (FDA) Bioresearch Monitoring Program was established in 1977 by a task force which included representatives from the drug, biologics, medical devices, veterinary medicine, and food programs areas. The need for such a program was evident in a survey of the conduct of studies involving FDA-regulated products by the FDA field inspection operation between 1972 and 1974. Following a review of the inspectional findings, the Congress mandated that FDA develop and implement an agency-wide program.

The Food and Drug Administration’s Bioresearch Monitoring Program protects the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials; determines the accuracy and reliability of pre-clinical data submitted to FDA in support of research or marketing applications; and assesses compliance with FDA's regulations governing conduct of clinical trials, including those for informed consent and ethical review.

The Bioresearch Monitoring Program at FDA's Center for Food Safety and Applied Nutrition (CFSAN) monitors clinical trials, institutional review board, and clinical investigators in accordance with Good Clinical Practice (21CFR Part 50 & 56), and nonclinical studies in accordance with Good Laboratory Practice (21 CFR Part 58) involved in supporting CFSAN regulated products and submissions.

For additional information please contact: cfsanbimo@fda.hhs.gov

Resources

FDA Bioresearch Monitoring
	Compliance Actions and Activities for Bioresearch Monitoring
	Clinical Trials and Human Subject Protection

                                                                                  Content current as of:
      09/18/2018
              
              
Regulated Product(s)
		 Food & BeveragesScience & Research (Food)

          
                        


                        CFSAN Risk & Safety Assessments
          CFSAN Social and Behavioral Research
          Chemistry Research
          Data Science
          Laboratory Methods
          Microbiology Research
          Reference Databases and Monitoring Programs
          Toxicology Research
          University Centers of Excellence
 
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