What are the regulations governing the approval of generic drugs?

In Washington, the regulations governing the approval of generic drugs are set by the Washington State Board of Pharmacy. Generic drugs are approved through an administrative process called the Abbreviated New Drug Application (ANDA) process. An ANDA is a form of drug application that is submitted to the FDA that contains detailed information on the drug’s active ingredients and safety, efficacy, and manufacturing process. In order to approve a generic drug, the FDA must ensure that it meets certain requirements. First, the generic drug must contain the same active ingredients in the same amount as the originally approved product. This is known as bioequivalence, which means that the generic drug must provide the same therapeutic effect as the original product. Second, the FDA requires that the generic drug must have the same route of administration, strength, dosage form, and labeling as the original product. Finally, it is also important to note that the FDA requires that a generic drug must meet the same manufacturing and quality standards of the original product. In addition to the ANDA process, generic drugs must also be approved by the Washington State Board of Pharmacy. The Board reviews the ANDA submissions and ensures that the drug is safe and effective. After an ANDA is approved, the generic drug is placed on the market with the same label as the original product. This ensures that the public is informed of the potential risks and benefits of the generic drug.

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What are the regulations governing the approval of generic drugs?

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