ANDAs Must Show Different Inactive Ingredients Do Not Affect Efficacy - FDA
This article was originally published in The Tan Sheet
Executive Summary
Applications for generic drug products with different inactive ingredients than the innovator drug must demonstrate that efficacy is unaffected, FDA says in a proposed rule revising the regulation on bioequivalence/bioavailability and the content and format of abbreviated new drug applications.
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FDA's final rule on bioavailability and bioequivalence for ANDAs requires "appropriate" sampling to establish a drug's steady state instead of sampling on three consecutive days as outlined in the proposed rule
Bioequivalence Final Rule Requires “Appropriate” Sampling For ANDA Tests
FDA's final rule on bioavailability and bioequivalence for ANDAs requires "appropriate" sampling to establish a drug's steady state instead of sampling on three consecutive days as outlined in the proposed rule