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 FDA convened the meeting to consider its 2011 draft guidance, which proposed designating on packaging whether tablets meet scoring guidelines.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
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.