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

Autor: Chiodin D; Acerta Pharma, South San Francisco, CA, USA., Cox EM; Denali Therapeutics Inc., South San Francisco, CA, USA., Edmund AV; Impact Clinical, LLC, Escondido, CA, USA., Kratz E; Denali Therapeutics Inc., South San Francisco, CA, USA., Lockwood SH; Denali Therapeutics Inc., South San Francisco, CA, USA.
Jazyk: angličtina
Zdroj: Clinical and translational science [Clin Transl Sci] 2019 Jul; Vol. 12 (4), pp. 334-342. Date of Electronic Publication: 2019 Apr 12.
DOI: 10.1111/cts.12635
Abstrakt: 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.
(© 2019 Denali Therapeutics Inc. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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