CDER stands for the Center for Drug Evaluation and Research. The CDER is a branch of the U.S. Food and Drug Administration, or the FDA. The CDER is responsible for regulating and evaluating new drugs before they are sold on the market. The center provides information so that doctors and patients can use drugs more safely.
According to the CDER, one of its main goals is to make sure the benefits of any drug evaluated outweighs its risks. “Drugs” can include other consumer products as well, including toothpaste, sunscreen, etc. The CDER evaluates:
- prescription drugs
- generic drugs
- over-the-counter drugs
If the CDER approves a drug and later finds out about more risks, the center will change the label on the drug to update patients to the risks, or the drug will be removed from the market.
According to the CDER, one of the best ways to decrease health risks while taking a drug is to ask your doctor questions such as:
- What is the name of the medication, and what is it for?
- How and when do I take it, and for how long?
- What are the side effects, and what should I do if they occur?
- Is this medication safe to take with all other medications, including over-the-counter medication, that I am taking?
To be approved by CDER, drug manufacturers must prove the drug is safe and effective. Clinical trials are performed to evaluate the safety and effectiveness of the drug, and to gain more information about how the drug works and any possible side effects associated with the drug.
To contact the CDER, visit them online at www.fda.gov/cder.


