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Assessments of the Impact of FDA's Regulatory Actions and Interventions

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Project TitleLong acting beta2 agonists (LABA) policies and drug utilization patterns
Date Posted 1-10-2014
Project StatusComplete
Project TypeProtocol based one-time assessment
Description Protocol and report for a project to assess the impact of the 2010 FDA regulatory action on long acting beta2 agonists (LABAs) on drug utilization patterns. The protocol represents a customized study design.
Medical ProductLong acting beta2 agonists (LABAs)
Health OutcomeChange in drug utilization patterns
Population / CohortContinuous members under age 65
Time PeriodJanuary 2004-June 2011
Workgroup LeadersMelissa Butler, PharmD, MPH, PhD, Kaiser Permanente of Georgia, Center for Health Research Southeast, Atlanta, GA and Esther Zhou, MD, PhD, Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD
Workgroup MembersFang Zhang, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; Mark Levenson, PhD , Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD; Ann Wu, MD, MPH, Children's Hospital Boston and Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; Solomon Iyasu, MD, MPH, Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD; Pingsheng Wu, PhD, Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Yu-te Wu, PhD, Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD; Darren Toh, ScD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; Monika Houstoun, PharmD, Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD; Sally Seymour, MD, Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD; Marsha Reichman, PhD, Center for Drug and Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD; Meghan A. Baker, MD, ScD, Brigham and Women's Hospital and Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA
Data SourcesMini-Sentinel Distributed Dataset (MSDD)
Deliverables Report of the Impact of 2010 FDA Regulatory Actions on LABA Medication Use

Protocol for the Assessment of FDA Regulatory Policies for Long Acting Beta2 Agonists

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Keywordsassessment protocol, impact of regulatory action, long acting beta2 agonists, LABA, salmeterol, formoterol, arformoterol, Butler, Zhou, Zhang, Levenson, Wu, Iyasu, Toh, Houstoun, Seymour, Reichman, Baker

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Page Updated: 2014