Center for Drug Evaluation and Research (CDER)
What is the Center for Drug Evaluation and Research (CDER)?
The Center for Drug Evaluation and Research (CDER) is a branch of the U.S. Food and Drug Administration (FDA) responsible for regulating and overseeing the safety and efficacy of prescription and over-the-counter drugs marketed in the United States.
The CDER regulates brand name drugs, generic drugs, and biological therapeutics. Its work encompasses more than just medicine, with antiperspirants, toothpaste, sunscreen, and dandruff shampoo all considered drugs.
While most biologics are regulated by the Center for Biologics Evaluation and Research (CBER), therapeutic proteins, monoclonal antibodies, and immunomodulators all fall under the CDER’s regulation.
What role does the CDER play in improving healthcare?
The CDER is most well-known for evaluating new drugs before they can be sold. Not only does this ensure that only legitimate drugs with health benefits that outweigh the risks are sold to individuals, but it also provides doctors and patients with the information they need to use and prescribe medicines appropriately.
The CDER plays a crucial role in evaluating the submissions of drug companies, going through the information provided to ensure the results of the clinical trials are favorable and that the labels contain all the necessary information. Its work increases trust in the pharmaceutical industry and the products they produce.