Bioequivalence Final Rule Requires “Appropriate” Sampling For ANDA Tests
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
ANDAs Must Show Different Inactive Ingredients Do Not Affect Efficacy - FDA
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.
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands