Types of FDA Audits

The Food and Drug Administration (FDA) supervises medical research studies through the Division of Scientific Investigations. The agency may conduct audits of medical research and testing facilities in order to ensure studies avoid bias and follow proper testing procedures. The investigator will review all case study data and may interview patients and doctors. In all types of audits, an FDA investigator checks the study for errors that affect the outcome.

Bioequivalence Audit

• The FDA usually conducts bioequivalence audits for new drug applications. This process refers to the use of an existing drug in a new product or a test of an already-approved drug application in the treatment of other conditions. The FDA usually only conducts a single audit for bioequivalence studies.

Routine Audit

• The FDA may conduct a routine audit at random—a warranted activity if an audit has not occurred in the past five years. An FDA inspector may decide to inspect a site within six months of approval to begin research. Other red flags that trigger a routine inspection include abnormally high enrollment rates in a study, as well as large studies to promote a pivotal drug. Making the switch from a prescription drug to an over-the-counter classification may also trigger a routine audit.

For-Cause Audit

• With for cause audits, the FDA has reason to suspect foul play in clinical research. Doctors who conduct clinical research outside their qualifications may trigger an audit. If test subjects send a complaint to the FDA or data determined by the study appears inconsistent with similar studies performed by other researchers, an FDA investigator will have reason to check out a research facility. A highly publicized drug can have the same effect.