Lexology February 28, 2023
That seems like it should be an obvious statement. FDA regulations draw important distinctions between brand drugs and generic drugs. A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials. Once approved, that drug becomes the reference list drug. If a manufacture wants to market a generic version of the drug, it need only prove the drug is equivalent to the reference list drug. Further, while the manufacturer of the brand or reference list drug is responsible for ensuring the adequacy and accuracy of the drug’s warning label, the generic manufacturer is only responsible for ensuring that the generic label is the same as the brand’s. Therefore, only brand manufacturers...
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