The 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.
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