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Article: Clinical Researchers - Heads up! HHS' Proposed Rules Focus on Clinical Research Enterprise.
- Article from:
- Mondaq Business Briefing
- Article date:
- August 20, 2004
CopyrightCOPYRIGHT 2004 Mondaq Ltd. 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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Executive Summary
Action: The Department of Health and Human Services' semiannual regulatory agenda, published June 28, 2004, outlines several clinical research rulemaking actions now under development, or already under agency review, relating to human subject protections, research misconduct, and investigational drugs. A recent court decision concludes a failure to participate in the regulatory rulemaking process may preclude future challenge to the adopted regulation, making comments on the proposed rules advisable.
Impact: As evidenced by these initiatives, the clinical research enterprise faces heightened federal oversight and enforcement, and ...