Food and Drug Administration - Disqualified/Restricted Lists for Clinical Investigators

The Food and Drug Administration (FDA) maintains a Disqualified/Restricted list for Clinical Investigators to ensure the integrity of clinical trials. This list identifies individuals who have been disqualified or restricted from conducting clinical investigations due to noncompliance with FDA regulations. Being on this list indicates serious concerns, such as issues with data integrity, patient safety, or ethical standards.

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234 Entities in Food and Drug Administration - Disqualified/Restricted Lists for Clinical Investigators
Entity NameEntity TypeEffective DateStatus

Gaman Walter N

IndividualJul 31, 2006active

Guy Matthew J

IndividualJul 25, 2008active

Halikas James A

IndividualJan 17, 2001active

Hendrick Kim C

IndividualDec 11, 2009active

Holland James A

IndividualAug 25, 2008active

Holmes Amy S

IndividualJan 11, 2011active

John Jr J T

IndividualNov 4, 1983active

Khooblall Khem L

IndividualJun 17, 1998active

Kleber Ronald

IndividualAug 6, 1981active

LaHaye Leon C

IndividualJun 18, 2002active

FAQs

Why is compliance with Food and Drug Administration - Disqualified/Restricted List for Clinical Investigators necessary?

The Food and Drug Administration (FDA) Disqualified/Restricted List for Clinical Investigators is crucial for maintaining high standards in clinical trials. this list identifies researchers who may not meet the requirements set by the fda. it is vital for compliance professionals to understand why adherence to this list is necessary.

Which companies should comply with Food and Drug Administration - Disqualified/Restricted List for Clinical Investigators?

The Food and Drug Administration (FDA) disqualified/restricted list for clinical investigators impacts companies in the pharmaceutical, biotechnology, and medical device industries. These organizations must comply to ensure that clinical trials are conducted by qualified individuals. Compliance helps protect patient safety, maintains data integrity, and ensures that products meet regulatory standards before reaching the market.