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FDA starts effort to respond to I.G. report on dwindling BiMo audits; Part 11 still a concern.(I.G. Report)(Food and Drug Administration)(Inspector General)
- Article from:
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BioResearch Compliance Report
- Article date:
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December 1, 2007
- Author:
- Cezanne, Jeannette
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Copyright informationCOPYRIGHT 2007 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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BOSTON FDA's Human Potential Clinical Steering Committee has recently issued reports and guidance documents in direct response to the unfavorable report issued in October by the HHS Office of the Inspector General (I.G.), which has triggered a congressional inquiry.
This was the first topic addressed by a number of representatives of FDA gathered in an informal conversational setting at the annual Human Research Protection Programs conference held Dec. 3-6, sponsored by Public Responsibility in Medicine and Research (PRIM&R).
The I.G. report, entitled: "The Food and Drug Administration's Oversight of Clinical Trials," found that FDA inspects only 1% of trial sites ...