What are the regulations governing the approval of generic drugs?

In California, generic drugs must meet certain regulations in order to be approved by the Food and Drug Administration (FDA). Generic drugs are copies of brand-name drugs, and are usually cheaper options for patients. The FDA requires that generic drugs have the same active ingredients, strength, dosage form, route of administration, quality, performance characteristics, and intended use as their corresponding brand-name drugs. This means that the generic drug must have the same medicinal properties, in the same exact form, as its brand-name counterpart. Generic drugs must also have an abbreviated new drug application (ANDA) approved by the FDA before they can be sold. This application includes detailed information about the drug’s manufacturing facility, ingredients, and chemistry. In addition, the FDA must conduct inspections of the manufacturing facility to ensure that the drug meets quality standards. Finally, generic drugs must prove that they are capable of producing results that are the same as the brand-name drugs through clinical tests conducted on humans. The FDA will only approve a generic drug if its results match those of the brand-name drug. By following these regulations, generic drugs can be safely approved and made available for sale. This helps patients save money on their medications, while also ensuring that they are getting the same quality and performance as their brand-name counterparts.

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What are the regulations governing the approval of generic drugs?

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