What are the regulations governing the testing and approval of generic drugs?

In Wyoming, the testing and approval of generic drugs are regulated by the United States Food and Drug Administration (FDA). In order for a generic drug to be approved, the manufacturer must demonstrate that the generic drug is safe and effective, and has the same active ingredients, strength, and dosage form as the name brand version. The FDA requires that the generic drug must be bioequivalent to the reference listed drug (RLD). Bioequivalence is the measure of how closely the generic drug matches the active ingredients and dosage form of the RLD. If the generic drug is not bioequivalent, it cannot be approved. In addition to the bioequivalence testing, the generic drug must also pass laboratory tests to ensure that it is free of contamination and meets all quality standards. The FDA also requires that the generic drug must have the same labeling as the RLD, and it must undergo stability testing. This testing is done to make sure that the generic drug remains stable under various conditions of storage. The manufacturer must then submit an abbreviated new drug application (ANDA) to the FDA for review. This application must include detailed information about the generic drug, including analytical data, stability data, and a summary of clinical trials. Once the FDA reviews the application, the generic drug may be approved for distribution in Wyoming.

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What are the regulations governing the testing and approval of generic drugs?

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