The Center for Drug Evaluation and Research (CDER), as the name suggests, is responsible for ensuring the safety and efficacy of the drugs distributed in the United States of America (USA) market. The CDER is basically the investigational unit of the United States Food and Drug Administration (USFDA) with the purpose of monitoring each drug which is being sold in the US. Along with reviewing the new drug applications, it also provides necessary information to users, doctors, and patients about the safe use of drugs; making sure that those drugs are consumed as intended to. As a part of USFDA, the CDER also ensures that both OTC and prescription drugs, which can fall under the class of generics or brand name should work well in favor of health to outweigh known risks.

Drugs Regulated by CDER

CDER regulates every drug product right from aspirin to cancer treatments. Broadly, it categorizes drugs as: Prescription, Over-The-Counter and Generic Drugs. It also regulates products which do not ideally fall under the drugs category such as fluoride toothpaste, dandruff shampoos, and sunscreens. By evaluating the benefits and risks of drugs, CDER allows end-users the access of new and better treatments.

Additionally, the CDER also looks after the marketing, research, development, and manufacturing of a drug. The CDER monitors that the marketed drugs are risk-free, and if any unexpected risk is being detected after approval; CDER has the authority to remove the product from the market and inform the public about the undetected risks.

To help organizations make a successful entry into the US market, Freyr provides complete guidance related to the regulations of CDER before launching a new drug. Are you compliant with CDER regulations? Contact our experts to know more