Updated: 2006-09-09
DISQUALIFIED/RESTRICTED/RESTRICTIONS REMOVED/ASSURANCES LISTS
FOR CLINICAL INVESTIGATORS
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:
- 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.
- All
clinical investigators who have agreed to certain restrictions with respect
to their conduct of clinical investigations.
- All clinical investigators who agreed to certain restrictions, which have
now been removed.
- 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
(http://www.fda.gov/ora/compliance_ref/debar/default.htm).
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