Federal Register Notice: FDA is making available a guidance for industry entitled “Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing” that provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on designing bioequivalence studies for modified-release dosage forms of potassium chloride. To download this guidance, click here. To view this notice, click here.
