Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications.
Journal
Clinical and translational science
ISSN: 1752-8062
Titre abrégé: Clin Transl Sci
Pays: United States
ID NLM: 101474067
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
20
12
2018
accepted:
24
02
2019
pubmed:
19
3
2019
medline:
31
7
2020
entrez:
19
3
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 30884199
doi: 10.1111/cts.12635
pmc: PMC6662388
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
334-342Informations de copyright
© 2019 Denali Therapeutics Inc. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.
Références
J Young Pharm. 2010 Jul;2(3):332-6
pubmed: 21042496
J Clin Invest. 2008 Apr;118(4):1344-7
pubmed: 18357347
N Engl J Med. 1997 Nov 13;337(20):1436-40
pubmed: 9358142
Br J Clin Pharmacol. 2016 Apr;81(4):582-6
pubmed: 26996741
Cancer Chemother Pharmacol. 1998;41(3):173-85
pubmed: 9443633
Blood. 2016 Nov 24;128(21):2504-2509
pubmed: 27881371
Fed Regist. 2005 Oct 20;70(202):61133-4
pubmed: 16237859