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Upcoming Meetings

This article was originally published in The Gray Sheet

Executive Summary

FDA workshop on clinical trials: FDA and the Society of Clinical Research Associates will hold an industry workshop Oct. 21-22 in Pittsburgh, Pa., on FDA clinical trial requirements, regulations, compliance and good clinical practices. Topics will include adverse event reporting, informed consent, institutional review board regulations and FDA inspections, clinical investigator inspections, meetings with FDA and FDA enforcement

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New CDRH deputies: FDA's device center is hiring two new deputies to serve under the center director: a deputy center director for policy and deputy center director for science. Applications for the two positions were accepted from early November through early December, and the agency's decision should be announced by the end of January. According to Barbara Zimmerman, a deputy director in CDRH's Office of Device Evaluation, the policy staffer will serve a similar function to the former associate director for regulations and policy, a post which has not been permanently filled since Kate Cook left CDRH in September (1"The Gray Sheet" Sept. 14, 2009). The deputy center director for science is a somewhat new position, created to tackle challenging scientific questions within FDA offices and those that rise to the level of the center director, Zimmerman said at a recent industry meeting

Regulatory News In Brief

New CDRH deputies: FDA's device center is hiring two new deputies to serve under the center director: a deputy center director for policy and deputy center director for science. Applications for the two positions were accepted from early November through early December, and the agency's decision should be announced by the end of January. According to Barbara Zimmerman, a deputy director in CDRH's Office of Device Evaluation, the policy staffer will serve a similar function to the former associate director for regulations and policy, a post which has not been permanently filled since Kate Cook left CDRH in September (1"The Gray Sheet" Sept. 14, 2009). The deputy center director for science is a somewhat new position, created to tackle challenging scientific questions within FDA offices and those that rise to the level of the center director, Zimmerman said at a recent industry meeting

CMS Will Cover Warfarin Gene Tests In Clinical Trials, But That's It

Medicare will only cover genetic testing for individual response to the blood-thinner warfarin in the context of controlled clinical studies, effective immediately, CMS said Aug. 3

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