Timothy R. Coté, MD, MPHProfessor of Regulatory Practice
Drug Regulation, Epidemiology, Public Health Practice, Tropical Diseases, Orphan Drugs, Anatomic Pathology
This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing).
This course will provide students with a broad background and understanding of the most current European Union regulatory requirements, strengthening their capacity to discuss, perform and address the regulatory requirements effecting licensure of products from the pharmaceutical and medical device industries.
Lee E, Ferguson D, Jernigan D, Greenwald M, Cote T, Bos J, Guarner J, Zaki S, Schucat A, Beall B, et al. "Invasive group-A streptococcal infection in an allograft recipient. A case report." J.Bone Joint Surg.Am. 2007;9:2044-7
Cote T, Kelkar A, Xu K, Braun M, Phillips M, I. "Orphan products: an emerging trend in drug approvals." Nature Reviews Drug Discovery 2010;9(1):84-U11
Braun M, Farag-El-Massah S, Xu K, Cote TR. "Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years." Nature Reviews Drug Discovery 2010;9(7):519-22
Talele SS, Xu K, Pariser AR, Braun M, Farag-El-Massah S, Phillips M, I, Thompson BH, Cote TR. "Therapies for Inborn Errors of Metabolism: What Has the Orphan Drug Act Delivered?" Pediatrics 2010;126(1):101-6
McNeil D, Davis C, Jillapalli D, Targum S, Durmowicz A, Cote TR. "Duchenne Muscular Dystrophy: Drug Development and Regulatory Considerations." Muscle & Nerve 2010;41(6):740-5
Freeman SN, Burke KA, Imoisili MA, Cote TR. "The Orphan Drug Act and the Development of Stem Cell-Based Products for Rare Diseases." Cell Stem Cell 2010;7(3):283-7
Burke K, Freeman S, Imoisili M, Cote T. "The Impact of the Orphan Drug Act on the Development and Advancement of Neurological Products for Rare Diseases: A Descriptive Review." Clinical Pharmacology & Therapeutics 2010;88(4):449-53
Cote TR, Xu K, Pariser AR. "Accelerating orphan drug development". Nature Reviews Drug Discovery 2010;9(12):901-2
|Timothy R. Coté, MD, MPH|
|Location:||Building 517, Room B142|