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Please review our Terms of Use for important information about FDA warning letters posted on the CIRCARE web site.
Key to abbreviations and information about FDA administrative actions
Dr.Paula Bickle. Barrett S. 2007-07-07: http://www.quackwatch.org/11Ind/bickle.html
egg yolk containing natural antibodies against candida albicans/tropicalis.Undated: http://www.circare.org/FOIA/ovimmune_consent.pdf (2)
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:
FDA Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
FDA CDER Warning Letters (see explanation at link): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm
FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm092185.htm
FDA Notice of Opportunity for Hearing (NOOH) Letters: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm143240.htm
FDA Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm143242.htm
FDA Debarment List: http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm
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. Accessed on 2009-06-29 at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.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. Accessed on 2009-06-29 at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.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. Accessed on 2009-06-29 at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm
Notes
1. Cavitat Medical Technologies, Inc. and Robert J. Jones vs. Aetna, Inc. Civil No. 04CV01849. Exhibit, Plaintiff's Response to Motion to Bifurcate or, Alternatively, Reset the Trial Date. USDC District of Colorado. 2005-12-28.
2. Source: Marilyn A. Coleman and Ovimmune, Inc. v. Sally W. Wiley et al. Case No. 2002CV0048. Common Pleas Court Union County, OH. Complaint (Exhibit A). 2002-02-21: http://www.circare.org/FOIA/2002cv0048_complaint.pdf
Last Updated: 2010-08-10
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