Open AccessRegulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications
Author(s) -
Chiodin Davy,
Cox Erica M.,
Edmund Anita V.,
Kratz Erica,
Lockwood Sarah H.
Publication year - 2019
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12635
Subject(s) - investigational drugs , regulatory affairs , food and drug administration , drug approval , agency (philosophy) , drug development , medicine , government (linguistics) , clinical trial , regulatory agency , human use , drug , drug trial , human services , political science , business , public administration , pharmacology , law , microbiology and biotechnology , pathology , biology , philosophy , linguistics , epistemology
Testing novel drugs on fellow human beings is fraught with potential ethical concerns; however, developing drugs to treat the wide spectrum of human diseases and disorders is a moral imperative. How do we best navigate the balance between protecting the individual vs. the greater good? Global government regulatory bodies are accountable for ensuring that medical experiments on human subjects are appropriately justified and subject to close oversight. In this article, we focus on two major global health authorities, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and the path to legally treating humans with new investigational products.