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  1. Development & Approval Process | Drugs

Pharmaceutical Quality Resources

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications.

The Center for Drug Evaluation and Research (CDER) established the Office of Pharmaceutical Quality (OPQ) to ensure a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all human drug product areas – new drugs and biological products, generics, biosimilars, over-the-counter drugs and certain compounded drugs.

The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.

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