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MontanaState83

10/20/19 9:03 PM

#220271 RE: dmlcento #220270

Wait, I thought MO affected statin absorption! You telling me that is not covered in the regs? Say it isn't so

johnking29

10/21/19 11:15 PM

#220413 RE: dmlcento #220270

Bio + Jesse: Maybe I missed it yet do either of you find it any bit unusual that the FDA is suddenly interested in "lack of absorption" due to "injesting Mineral Oil at mealtime"? To suddenly note that "recent studies imply a problem with 'absorption ability' of anything due to Mineral Oil" seems quite suspect right now. Cannot imagine this is not going to be a major point by the FDA @ AdCom... Your thoughts?

(Long and Following both of you Since 2011...)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.302