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 This guidance finalizes the draft guidance issued June 16, 2016, which provides manufacturers of chewable tablets for human use with the Center for Drug Evaluation and Research's current thinking on the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.
Document
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 Ta...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
83 FR 42306
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Quality Attribute Considerations for Chewable Tablets; Guidance for Industry; Availability,” thefederalregister.org (August 21, 2018), https://thefederalregister.org/documents/2018-17967/quality-attribute-considerations-for-chewable-tablets-guidance-for-industry-availability.