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Tablet Scoring Guidance Could Drop Patient Testing Recommendation

 
• By Derrick Gingery

FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology unanimously rejects an idea to test tablet scoring in the relevant patient population, saying there is too much potential variability.

FDA’s tablet scoring guidance may see provisions removed that would require testing in patients after an advisory committee said patient behavior is too unpredictable to make the approach reliable.

FDA in a 2011 draft guidance wanted manufacturers to test whether their tablet scoring convention allowed patients taking the medicine...

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