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What programs does the FDA offer?

FDA-Regulated Products and Facilities ProgramImports ($Billions)Exports ($Billions)Human and Animal Drugs$93.62$31.67Human Food and Cosmetics$158.90$122.90Medical Devices$68.01$58.69Tobacco$1.58$1.054 more rows Aug 17, 2022

Does the FDA inspect clinical trials?

The U.S. Food and Drug Administration (FDA) conducts inspections to protect the rights, safety, and welfare of research study participants, verify the accuracy and reliability of study data, and assess compliance with FDA regulations for the conduct of clinical trials.

What happens if you dont follow FDA guidelines?

The range of enforcement activities include issuing a letter notifying the individual or firm of a violation and requesting correction, to criminal prosecution of the individual or firm. Adulteration or misbranding is usually the result of an individual failing to take steps to assure compliance with the law.

What is BIMO listing?

The FDA Bioresearch Monitoring Program (BIMO) develops guidelines for inspections of clinical investigators, sponsors, and Institutional Review Boards (IRBs).

What is BIMO listing?

The FDA Bioresearch Monitoring Program (BIMO) develops guidelines for inspections of clinical investigators, sponsors, and Institutional Review Boards (IRBs).

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