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Tuesday, 10/16/2018 3:25:49 AM

Tuesday, October 16, 2018 3:25:49 AM

Post# of 462851
Additionally, the agency today issued the final guidance, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease, which was issued as draft guidance in December 2017. This final guidance addresses the topic of finding treatments that address the underlying molecular changes (e.g., genetic variants) that often cause or contribute to diseases, including uncommon, or rare molecular changes that are present in a small subset of patients.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm623411.htm
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