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=As we have done in past years, IMARC examined the warning letters posted on the FDA’s website to compile the top findings from BIMO inspections. This year, we are reflecting on the top findings of previous years and discussing trends seen in 2018.
Topics: FDA Warning Letters, BIMO Program, FDA Inspections
Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the rights, safety and welfare of human research subjects have been protected and that the validity of research data is accurate to support a marketing application. When serious violations are found during a BIMO inspection, a warning letter is issued. These BIMO inspection metrics provide the common findings that are found during these inspections by fiscal year (FY). According to the United States federal government, the FY begins on October 1st of the previous calendar year and ends on September 30th, the year in which it is numbered.
Topics: FDA Warning Letters, FDA, BIMO Program