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Recent Developments in FDA Regulation of Genetic Tests
Implications for Pharmaceutical, Diagnostic Companies and Clinical Laboratories
Wednesday, July 14, 2010
Recent actions by FDA and in Congress make it clear that big changes may be ahead for FDA regulation of genetic and other laboratory-developed tests. Please join us for an in-depth discussion of the potential impact of proposed regulatory and legislative changes on companies' activities and how to effectively respond to these developments.
Speakers:
Jim Stansel, Co-Head of the Global Life Sciences Group, Former Acting General Counsel of the United States Department of Health & Human Services
Peter Goodloe, Counsel, Former Healthcare and FDA Counsel of the House Office of Legislative Counsel
Gail Javitt, Counsel, Former Law and Policy Director at the Genetics and Public Policy Center, at the John Hopkins University