Acceptability of Draft Labeling to Support ANDA Approval Guidance for Industry
Acceptability of Draft Labeling to Support ANDA Approval Guidance for Industry
Acceptability of Draft Labeling to Support ANDA Approval Guidance for Industry INTRODUCTION This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs) under section 505(j)(2)(A)(v) of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s implementing regulations (21 CFR 314.94(a)(8)). This guidance is…