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 FDA convened the meeting to consider its 2011 draft guidance, which proposed designating on packaging whether tablets meet scoring guidelines.
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FDA issues guidance on splitting tablets
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Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.