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FDA Warning Letters and Regulatory Actions F – L

F  | G  | H  | I  | J  | K  | L  

Alphabet soup: NIDPOE: Notice of Initiation of Disqualification Proceedings and Opportunity to Explain; NOOH: Notice of Opportunity for Hearing; PEDS: one or more studies enrolled children. Clinical investigators received warning letters unless otherwise indicated. Follow this link to find more information about FDA administrative actions . Follow this link for an overview of FDA warning letters by year and type .

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FDA Warning Letters Issued to Clinical Investigators Cont. (M – R)

Key
PEDS: one or more studies enrolled children.
CBER: Center for Biologics Evaluation and Research.
CDER: Center for Drug Evaluation and Research.
CDRH: Center for Devices and Radiological Health.

Sources:
(External) FDA Archived Warning Letter and Response Search: November 1996 to March 2006
(External) FDA Warning Letters Indexed by Date: March 2006 to present
(External) FDA Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings
Requests under the Freedom of Information Act.

Warning Letter: A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions. FDA Center for Drug Evaluation and Research, Division of Scientific Investigations. Accessed 2006-03-19 from (External) http://www.fda.gov/cder/Offices/DSI/enforcement.htm

NIDPOE: A NIDPOE letter informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration's regulations. Generally, FDA issues a NIDPOE letter when it believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor. FDA Center for Drug Evaluation and Research, Division of Scientific Investigations. Accessed 2006-03-19 from (External) http://www.fda.gov/cder/Offices/DSI/enforcement.htm

NOOH: The Notice of Opportunity for Hearing provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner. FDA Center for Drug Evaluation and Research, Division of Scientific Investigations. Accessed on 2006-03-19 at: (External) http://www.fda.gov/cder/Offices/DSI/enforcement.htm


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Notes

1. For information on the circumstances described in FDA's warning letter to Dr. Fabre, see: One Dead Guinea Pig. Greg Harmon. Houston Press. 2005-07-28. Accessed on 2007-03-31 at: (External) http://www.houstonpress.com/2005-07-28/news/one-dead-guinea-pig/

According to the FDA Clinical Investigator Inspection List, pre-approval Drug Audit (DA) inspections, e.g., study-oriented inspections in which the focus is on verification of study data, were conducted at Dr. Fabre's clinic on 1980-11-13, 1984-11-08, 1986-01-29, 1990-02-05, and 2002-03-20. Two inspections were classified as VAI, (Voluntary Action Indicated): in 1984 the consent form was inadequate, and in March, 2002 subject records were inadequate and incorrect. On 1983-04-15 FDA conducted an inspection For Cause (FC), an investigator-oriented inspection in which the focus is on the conduct of the study by the Clinical Investigator. This inspection was also classified VAI . FDA recorded objections to inadequate consent forms, failure to follow protocol, inaccurate and incorrect subject records, failure to notify the IRB of changes, failure to make required submissions to the IRB , and failure to report adverse reactions. On 2002-10-21 and 26 FDA conducted the inspection which prompted the Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIPDOE) letter of 2005-01-19. FDA Clinical Investigator Inspection List (CLIIL). Accessed on 2005-12-12 at: (External) http://www.fda.gov/cder/regulatory/investigators/default.htm

Information from the FDA Bioresearch Monitoring Information System File indicates that Dr. Fabre was the principal investigator for 86 studies conducted under FDA IND regulations. Since this database doesn't include bioequivalency studies, like the one in which Mr. Polsgrove died, or drug studies exempt from FDA IND regulations, we can only guess at the total number of studies conducted over a career spanning three decades.

The same FDA database holds 65 entries for dates on which the IRB (Research Testing Inc., Human Investigation Committee) located at Dr. Fabre's clinic approved studies conducted at the clinic by Dr. Fabre.

On 1993-10-05 FDA received (and accepted) notification of a study conducted at the Fabre Research Clinic by principal investigator John A. Rodriguez M.D., despite the fact that this individual had no license to practice medicine in the U.S. Mr. Rodriguez may be the unlicensed individual the identity of whom is redacted in the FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain issued to Dr. Fabre on 2005-01-19. FDA Bioresearch Monitoring Information System File (BMIS) for Downloading. Accessed on 2005-12-12 at: (External) http://www.fda.gov/cder/foi/special/bmis/index.htm

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Last Updated: 2008-07-23

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