This guidance provides manufacturers of chewable tablets for human use with the Center for Drug Evaluation and Research’s (CDER) current thinking on the critical quality attributes that should be assessed during the development of these drug products. This guidance also provides recommendations for sponsors/applicants regarding the submission of developmental, manufacturing, and labeling information for chewable tablets in applications. The recommendations in this guidance apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain chemistry, manufacturing, and controls (CMC) supplements to these applications. Some of the recommendations about the submission of developmental information may also apply to investigational new drug applications (INDs). The recommendations about assessing critical quality attributes apply to all immediate release (IR) chewable tablets for human use, including non-application products.