World Library  
Flag as Inappropriate
Email this Article

Experimental drug

Article Id: WHEBN0016256107
Reproduction Date:

Title: Experimental drug  
Author: World Heritage Encyclopedia
Language: English
Subject: Remacemide, Rotarod performance test, NSI-189, Glossary of clinical research, Pharmacology
Publisher: World Heritage Encyclopedia

Experimental drug

An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions.

In the United States, the body responsible for approval is the U.S. Food and Drug Administration (FDA), which must grant the substance Investigational New Drug (IND) status before it can be tested in human clinical trials. IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy.[1]

In Canada a Clinical Trial Application (CTA) must be filed before starting a clinical trial. Health Canada will review the application and will notify the sponsor within 30 days if it is found to be deficient.[2]

In Europe, the application process to perform a clinical trial takes place on a country-by-country basis. A sponsor must apply for approval in each country in which it intends to have study sites. A sponsor also must register their proposed clinical trial in EudraCT, a database of all in European clinical trials that is operated by the European Medicines Agency.[3]

See also


  1. ^ MaRS. Clinical trial authorization process: US. (2010).
  2. ^ MaRS. Clinical trial authorization process: Canada. (2010).
  3. ^ MaRS. Clinical trial authorization process: EU (UK). (2010).

External links

  • Experimental drug entry in the public domain NCI Dictionary of Cancer Terms

 This article incorporates public domain material from the U.S. National Cancer Institute document "Dictionary of Cancer Terms".

This article was sourced from Creative Commons Attribution-ShareAlike License; additional terms may apply. World Heritage Encyclopedia content is assembled from numerous content providers, Open Access Publishing, and in compliance with The Fair Access to Science and Technology Research Act (FASTR), Wikimedia Foundation, Inc., Public Library of Science, The Encyclopedia of Life, Open Book Publishers (OBP), PubMed, U.S. National Library of Medicine, National Center for Biotechnology Information, U.S. National Library of Medicine, National Institutes of Health (NIH), U.S. Department of Health & Human Services, and, which sources content from all federal, state, local, tribal, and territorial government publication portals (.gov, .mil, .edu). Funding for and content contributors is made possible from the U.S. Congress, E-Government Act of 2002.
Crowd sourced content that is contributed to World Heritage Encyclopedia is peer reviewed and edited by our editorial staff to ensure quality scholarly research articles.
By using this site, you agree to the Terms of Use and Privacy Policy. World Heritage Encyclopedia™ is a registered trademark of the World Public Library Association, a non-profit organization.

Copyright © World Library Foundation. All rights reserved. eBooks from Project Gutenberg are sponsored by the World Library Foundation,
a 501c(4) Member's Support Non-Profit Organization, and is NOT affiliated with any governmental agency or department.