SAGE Journal Articles
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Article 1: Garmendia, C. A., Epnere, K., Bhansali, N. (2018). Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations. Therapeutic Innovation & Regulatory Science.
Abstract: The US Food and Drug Administration (FDA) ensures clinical trials meet regulatory/ethical standards through inspections. If FDA Investigators observe potential violations of regulatory requirements during an inspection, a firm will receive a Form FDA 483, Inspectional Observations. Violations cited have resulted in the death of human research subjects, prosecution of research personnel, and denial of approval for new medical products. Objectives included the standardization of Violation Themes cited for analysis by inspection firm type, geographic location, and Violation Theme citation to provide insight into regulatory violations.
Article 2: Hall, T. E. & O’Toole Jr., L. J. (2004). Shaping Formal Networks Through the Regulatory Process. Administration & Society, 36(2), 186-207.
Abstract: Recent research has shown that, at the federal level, new or amended programs typically create networks consisting of multiactor structures spanning governments, sectors, and/or agencies. This study examines the implementation structures created through the regulatory process. We find that in a majority of cases the regulatory process adds to the complexity of implementation patterns; previously simple implementation structures often became more complicated and new actors are brought into the process. Rules also serve a key function in clarifying the general language that is often used by Congress. These findings have implications for the study and practice of public administration.