FDA Audit Procedures
The Food and Drug Administration is a division of the U.S. Department of Health and Human Services. The FDA has the responsibility of approving and regulating food, medications and medical devices. The administration's investigators may conduct an audit of clinical research to make sure it is being conducted properly.
Guidelines
FDA audits may be conducted at random. Other times, the audit is for cause, meaning the FDA has a reason to conduct it. If a research team is testing a drug that is outside its medical specialty, the FDA will have just cause to conduct an audit. If medical subjects send a complaint to the FDA or data obtained from a clinical study is radically different from other studies testing the same medication, these red flags will lead to an audit. "For cause" audits also apply to products made highly popular by the media. Any manufacturer using studies to try to switch a prescription drug to an over-the-counter medication will usually receive an FDA audit.
Notification
If the federal agency intends to investigate clinical drug trials or the use of medical devices, it will send out FDA Form 482: Notice of Inspection. An investigator will arrange a convenient time when he can meet with the drug study's sponsor. The FDA will usually arrange for meetings a few days to several weeks after sending out Form 482. Clinical sponsors should never delay audits, as this will cause an FDA investigator to scrutinize the study more carefully.
Review
FDA audits usually last between three and five days. Investigators must receive access to all requested records. Information on all subjects enrolled in the study, in addition to their informed consent forms, should be available. Detailed clinical research, problems with the study and safety practices should be provided. An agent will want to see the credentials of all medical professionals conducting the study. The FDA representative also may want to question staff and study subjects.
Sanctions
The FDA is concerned with the integrity of medical data. Any study that appears to be rigged to promote a medication or therapy will require sanctions, formally described as Official Action Indicated. If the study is in compliance with FDA guidelines, the site will receive a No Action Indicated letter. Practices that do not severely damage the study will receive a Voluntary Action Indicated citation.
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