By Jeanene Dunn, OHM Staff
Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans.
Before prescription and over-the-counter medications can be sold to consumers in the U.S., they must be evaluated to make sure they are safe, effective and work according to the product claims.
As American consumers, we benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).
The center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand name and generic, work correctly and that their health benefits outweigh their known risks.
HOW THE PROCESS WORKS
Drug companies seeking to sell a new drug in the United States must first test it and send the evidence gathered from their tests to CDER to prove that the drug is safe and works for its intended use.
A team of CDER physicians, statisticians, chemists, pharmacologists and other scientists review the company’s data and proposed labeling. Before a drug is submitted to the FDA for approval, the company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans.
Next, a series of tests in people is started to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The CDER doesn’t actually test drugs but does conduct limited research in the areas of drug quality, safety and effectiveness standards.
To learn more about Accelerated Approval, approval designations and other requirements, visit
https://www.fda.gov/drugs/development-approvalprocess-drugs
Source: The U.S. Food and Drug Administration\
