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

• Published in: Clinical 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
• Language: English
• 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

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...