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  1. Science and Research | Drugs

Drug Quality Sampling and Testing Programs

Back to Regulatory Science at CDER

 

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Drug Quality: Postmarket Sampling and Testing

Learn about CDER's Regulatory Science programs of research.FDA's requirements for approval of new and generic drugs and biologics are among the highest standards across the globe. Prior to FDA approval, the manufacturer must prove the product is safe, effective, and high quality.

To help assure safe and effective drugs are sold in the United States, we test selected drugs in FDA laboratories. This includes active pharmaceutical ingredients (API) used to make the product and the finished drug product sold to consumers. We test using the same standards that are part of the drug approval process for identity, strength, purity, and bioavailability, which is also used to establish bioequivalence. 

We are committed to protecting patients from potentially unsafe, non-effective or poor-quality drugs. Postmarket surveillance testing is one way that FDA works to help ensure patients have access to safe, effective, quality drugs.

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