title: FDA's Proposed Guidance for Laboratory Developed Tests: How Should Regulators Balance the Risks and Promise of Innovation in Clinical Genetics?
authors.affiliation: National Institutes of Health, Department of Bioethics.
authors.forename: Michelle
authors.initials: M
authors.lastname: Bayefsky
authors.affiliation: National Institutes of Health, Department of Bioethics.
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Berkman