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Draft Label Comprehension Study Guidance Stresses Quality And Quantity

This article was originally published in The Tan Sheet

Executive Summary

FDA wants sponsors conducting label comprehension studies to take into account subjects' thought processes - reflected in their verbatim answers to test questions

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Final guidance for label comprehension studies replaces several draconian draft recommendations with more flexible "common sense" measures, but drug sponsors may need to conduct significantly larger, more expensive studies and meet more extensively with the agency, experts say

Label Comprehension Guidance May Improve Switch Outlook

Final guidance for label comprehension studies replaces several draconian draft recommendations with more flexible "common sense" measures, but drug sponsors may need to conduct significantly larger, more expensive studies and meet more extensively with the agency, experts say

Label Comprehension Guidance May Improve Switch Outlook

Final guidance for label comprehension studies replaces several draconian draft recommendations with more flexible "common sense" measures, but drug sponsors may need to conduct significantly larger, more expensive studies and meet more extensively with the agency, experts say

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