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an overview of FDA warning letters by year and type
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.
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
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 on 2006-03-19 at: (External)
http://www.fda.gov/cder/Offices/DSI/enforcement.htm
Last Updated: 2008-07-21
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