10 Things to Know about CDER’s Pharmaceutical Quality Functions

This training session will focus on 10 Things to Know about CDER’s Pharmaceutical Quality Functions. Basically, the CDER is the US Government agency. The full form of CDER is Centre for Drug Evaluation and Research.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
Pharmaceutical quality provides the confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed. When CDER receives a prescription drug application for approval, we evaluate whether the drug can be made to consistently meet quality standards. Pharmaceutical quality is about more than just the quality of the drug itself. It includes the manufacturing facilities and the processes used to manufacture the drug. Some of CDER’s pharmaceutical quality functions occur before a prescription drug is approved and reaches patients. CDER also monitors drugs on the market and the facilities making them to ensure continued quality.
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