Zdrowie i gospodarka · 29/10/2003

Requirements for Submission of In Vivo Bioequivalence Data; Proposed Rule

The Food and Drug Administration (FDA) is proposing a rule change requiring generic drug applicants to submit data from all bioequivalence studies conducted on a specific drug product formulation, rather than just those that demonstrate the product meets bioequivalence criteria. This change aims to improve the FDA's evaluation of generic drug applications and better understand how changes in formulation affect product performance.