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FDA Warning Letters and Regulatory Actions A – E

A  | B  | C  | D  | E

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 .

Key to Abbreviations

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FDA Warning Letters Issued to Clinical Investigators Cont. (F – L)

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 2006-03-19 from (External) http://www.fda.gov/cder/Offices/DSI/enforcement.htm

Key
PEDS: one or more studies enrolled children.
SUSP: suspension of institutional review board (IRB) authority to review and approve new research subject to FDA regulations.
CBER: Center for Biologics Evaluation and Research.
CDER: Center for Drug Evaluation and Research.
CDRH: Center for Devices and Radiological Health.


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Last Updated: 2008-07-23

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