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

In North Dakota, all drugs, including generic drugs, must be approved by the U.S. Food and Drug Administration (FDA) before they can be sold. For generic drugs, the FDA requires that the drug is comparable to the original brand-name drug in terms of safety, strength, quality, how the drug works, and how it is taken. Additionally, the FDA must approve any manufacturing site to ensure the safety and quality of the generic drug. To ensure that a generic drug is as safe and effective as the brand-name drug, the FDA evaluates data from scientific studies that compare the generic drug to the original brand-name drug. The FDA also looks at additional factors, such as the behavior of the generic drug in the body, how long it takes to break down, and how it interacts with other drugs. The FDA also confirms that the active ingredient in the generic drug is the same as the active ingredient in the brand-name drug. This means that the generic drug must be of the same quality and strength as the original brand-name drug. In addition, the FDA makes sure that the inactive ingredients do not interfere with the effectiveness of the generic drug. Once the FDA is satisfied that the generic drug meets all of the required standards, it grants approval and the generic drug can then be marketed and sold in North Dakota. The FDA continues to monitor all drugs, including generic drugs, to ensure that they remain safe and effective.

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

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