FDA Issues Draft Guidance on Chewable Tablets

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-16-2016 13:50


The US Food and Drug Administration (FDA) has issued draft guidance, Quality Attribute Considerations for Chewable Tablets, to provide manufacturers of chewable tablets for human use FDA's Center for Drug Evaluation and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.

The draft guidance also provides recommendations about submitting developmental, manufacturing, and labeling information for chewable tablets that must be approved by CDER before they can be distributed. The recommendations in the guidance apply mainly to new drug applications, abbreviated new drug applications, and certain chemistry, manufacturing, and controls supplements to these applications. Some of the recommendations about the submission of developmental information may also apply to investigational new drug applications. The recommendations about assessing critical quality attributes apply to all chewable tablets for human use, including non-application products.

Source: FDA


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