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 Name | Entity Type | Effective Date | Status |
|---|---|---|---|
Copelan Herbert W | Individual | Aug 19, 1966 | active |
DeAbate Carl Andrew | Individual | Feb 5, 2004 | active |
Edwards Thomas B | Individual | Jan 26, 1998 | active |
Fabre Louis F | Individual | Jun 23, 2008 | active |
Feurst Samuel I | Individual | Oct 2, 1984 | active |
Franklin William C | Individual | Nov 9, 1982 | active |
Gamarra Miguel H | Individual | May 31, 1983 | active |
Garcia Julio M | Individual | Oct 19, 1995 | active |
Gelfand Michael C | Individual | Sep 11, 1981 | active |
Gatenby Robert A | Individual | Feb 16, 2023 | active |
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.
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