How is a drug approved for testing?
All clinical research studies in Canada must be authorized by the Health Products and Food Branch (HPFB) of Health Canada. In the U.S. it is the Food and Drug Administration. A pharmaceutical company must have their proposal for a clinical research study approved by one of these authorities before proceeding with study in their respective countries.
The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans. Detailed information about this process from the FDA is available through the following link: http://www.fda.gov/fdac/special/newdrug/ndd_toc.html Who can be in a Clinical Study? People with the condition being studied as well as healthy people can volunteer to participate in different studies. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the condition being studied. Each study has specific requirements such as age, sex or medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician prior to parti
A. The U.S. Food and Drug Administration or FDA typically must authorize a drug company’s proposal to conduct a clinical study. Before the FDA gives authorization for a study a drug company must do years of preclinical or laboratory research before they can begin testing in humans. This research often involves years of experiments with animal and human cells. The compounds are also extensively tested in animals. If this stage is successful the pharmaceutical company provides this data to the FDA requesting approval to begin testing in humans.
The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans. It should help to know that even investigational treatments are well-tested for safety before their use in our clinical studies.
