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Updated: 2006-09-09


FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for investigations involving human subjects, to help protect the rights, safety, and welfare of these subjects.

The following hyperlinked lists contain the names of:

  1. All clinical investigators who have been disqualified or "totally restricted." FDA may disqualify a clinical investigator if the clinical investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA. A disqualified or totally restricted clinical investigator is not eligible to receive investigational drugs, biologics, or devices.
  2. All clinical investigators who have agreed to certain restrictions with respect to their conduct of clinical investigations.
  3. All clinical investigators who agreed to certain restrictions, which have now been removed.
  4. All clinical investigators who, under regulations in effect until 1987, have provided FDA with adequate assurances of their future compliance with requirements applicable to the use of investigational drugs and biologics.

FDA also makes available a separate list of firms or persons debarred pursuant to the debarment provisions of the Federal Food, Drug, and Cosmetic Act (


Page Reformatted: November 21, 2001 (tc)