Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications

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 govern...

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Bibliographic Details
Published inClinical and translational science Vol. 12; no. 4; pp. 334 - 342
Main Authors Chiodin, Davy, Cox, Erica M., Edmund, Anita V., Kratz, Erica, Lockwood, Sarah H.
Format Journal Article
LanguageEnglish
Published United States John Wiley & Sons, Inc 01.07.2019
John Wiley and Sons Inc
Wiley
Subjects
Annual reports
Clinical trials
Corporate sponsorship
Documentation
Drugs
Experiments
FDA approval
Food
Human subjects
Medical research
Patient safety
Studies
Tutorial
United States > US
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Summary: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.
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All authors contributed equally to this article.
ISSN:1752-8054
1752-8062
1752-8062
DOI:10.1111/cts.12635