FDA Panel Backs Split-Tablet Stability Test, With Reservations
This article was originally published in The Tan Sheet
Executive Summary
FDA wants manufacturers to demonstrate split tablets are safe under ideal conditions. Panelists concur, but wonder how useful the data will be to consumers. FDA convened the meeting to consider its 2011 draft guidance, which proposed designating on packaging whether tablets meet scoring guidelines.
You may also be interested in...
FDA’s Top-Four Tablet Scoring Concerns To Get Advisory Committee Review
The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will vote on some aspects of FDA’s draft scoring guidance, potentially giving generic industry a clue of future agency actions.
Regulatory News In Brief
FDA issues guidance on splitting tablets
US FDA’s Standard Application Assessment Makes A Comeback
After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.