miércoles, 29 de mayo de 2024

10 Things to Know about CDER’s Pharmaceutical Quality Functions

https://www.fda.gov/drugs/things-know-about/10-things-know-about-cders-pharmaceutical-quality-functions?utm_medium=email&utm_source=govdelivery 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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