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

In California, generic drugs must meet the same safety and effectiveness standards established for brand name drugs in order for them to be approved for use. The regulations governing the testing and approval of generic drugs are designed to ensure that generic drugs are equivalent to their brand-name counterparts in terms of safety, efficacy, and quality. The first step in the approval process is to assess the drug’s active ingredient. The drug must contain the same active and concentration levels as the corresponding brand-name drug. Then, all other components of the drug must be evaluated to ensure they are all safe. The drug’s manufacturing, packaging, and labeling must then be evaluated and must meet all of the requirements of California’s pharmaceutical laws. Once these evaluations are complete and the drug meets all of the applicable requirements, it is approved for use by California. Generic drugs must also undergo a bioequivalence testing to ensure that the generic drug is as effective and safe as its brand-name counterpart. The results from these tests must be submitted to the Food and Drug Administration (FDA) for final approval. After the FDA grants approval for the generic drug, it is then available for sale in California.

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