Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


US FDA slow in debarring clinical investigators, should extend authority to devices

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration fails to debar quickly enough clinical investigators convicted of contravening medical product regulations from engaging in research, a Government Accountability Office report has revealed1. The report also calls for the FDA’s debarment authority to be extended to medical devices so that it is consistent with the agency’s debarment authority for drugs and biologics; the agency’s current debarment authority does not fully extend to involvement with medical devices.




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts