(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) recently announced it has stepped up its efforts to prevent noncompliant investigators and others from participating in new product development. The FDA's procedures for debarment and disqualification have been enhanced to better protect participants in clinical studies and for ensuring the safety and effectiveness of the medical products marketed to the U.S. public.

Compliance with the FDA's statutes and regulations is key to protecting clinical study participants and the general public. The new debarment and disqualification procedures will also help ensure that sponsors of clinical studies do not unknowingly use individuals who potentially may be debarred or disqualified by the FDA.

“The FDA views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,” says Norris Alderson, the FDA's associate commissioner for science. “We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”

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