FDA Panel Backs Split-Tablet Stability Test, With Reservations
This article was originally published in The Tan Sheet
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 FDA convened the meeting to consider its 2011 draft guidance, which proposed designating on packaging whether tablets meet scoring guidelines.
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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.
FDA issues guidance on splitting tablets
However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.