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Citizen Petition Proposed Rule Would Have Minimal Device Center Impact

This article was originally published in The Gray Sheet

Executive Summary

FDA's proposed rule winnowing actions that can be requested by citizen petitions is unlikely to have a significant impact on the Center for Devices and Radiological Health, staffers report. While the reg likely would cut down on the number of petitions filed, officials point out that the center has neither a backlog nor a persistent problem with "nuisance" petitions.

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HHS issues conflict of interest draft guidance: "1Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection" recommends taking measures such as separating responsibility for financial and research decisions and establishing CoI committees to verify the absence of financial interests. Aimed at individuals and organizations engaged in human subjects research, the March 31 guidance provides points to consider and aligns with December 2001 GAO recommendations calling on HHS to develop best practices for managing investigator and institutional financial CoI in biomedical research. Comments on the guidance are due by May 30...

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