Experimental drug
An experimental drug is a
United States
In the United States, the body responsible for approval is the
Emergency Use Authorization(EUA)
The FDA has the authority to issue EUAs for medical products, including drugs and vaccines, during public health emergencies. This mechanism was prominently utilized during the COVID-19 pandemic, allowing for the rapid deployment of vaccines and therapeutics to address the crisis. The process for EUA includes the determination of a public health emergency, review of available scientific evidence, and consideration of the potential benefits and risks of the product.[3]
Canada
In Canada, a Clinical Trial Application (CTA) must be filed with the Health Products and Food Branch (HPFB) of Health Canada before starting a clinical trial. If the clinical trial results show that therapeutic effect of the drug outweighs negative side effects then the sponsor can then to file a New Drug Submission.[4]
European Union
Clinical trials in the European Union (EU) are regulated by the European Medicines Agency (EMA). Beginning in 2019 all applications for clinical trials must use a centralized EU portal and database. All clinical trial results will available to the public with the summary written in layperson's language.[5]
See also
- Off-label treatment
- List of investigational drugs
References
- ^ "How Drugs are Developed and Approved". U.S. Food and Drug Administration. Retrieved July 27, 2018.
- PMID 32576276.
- ^ Commissioner, Office of the (2024-03-04). "Emergency Use Authorization". FDA.
- ^ "How Drugs are Reviewed in Canada". Government of Canada. 8 January 2001. Retrieved July 27, 2018.
- ^ "European Medicines Agency – Clinical Trials Regulation". European Medicines Agency. Archived from the original on July 30, 2018. Retrieved July 30, 2018.
External links
- Experimental drug entry in the public domain NCI Dictionary of Cancer Terms
This article incorporates