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The agency provides quality, development, manufacturing, and labeling recommendations.
On June 16, 2016, FDA published guidance on the Center for Drug Evaluation and Research’s (CDER) thinking in regards to the assessment of critical quality attributes in the development of chewable tablets. The guidance also addresses the submission of developmental, manufacturing, and labeling information in new drug applications (NDAs) and abbreviated NDAs (ANDA) for CDER approval. The guidance also applies to certain chemistry, manufacturing, and controls (CMC) supplements to NDAs and ANDAs.
Critical quality attributes that should be established during early development include hardness, dissolution, and disintegration of the chewable tablet. FDA also recommends the following when developing chewable tablets:
The guidance provides labeling information, a chewing difficulty index, and a simulated salivary fluid composition appendix.