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Zdrowie i gospodarka · 8/21/2018

Quality Attribute Considerations for Chewable Tablets; Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Quality Attribute Considerations for Chewable Tablets." This guidance finalizes the draft guidance issued June 16, 2016, which provides manufacturers of chewable tablets for human use with the Center for Drug Evaluation and Research's current thinking on the critical quality attributes that should be assessed during the development of these drug products.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →