FDA warns anes­the­si­ol­o­gist for run­ning clin­i­cal in­ves­ti­ga­tions with­out an IND

Mag­gie Jef­fries, own­er of Hous­ton-based Avan­ti Anes­the­sia, has run afoul of the FDA’s rules on clin­i­cal in­ves­ti­ga­tions, ac­cord­ing to a warn­ing let­ter re­leased to­day, with the agency not­ing that the com­bo of drugs she used put some surgery pa­tients at in­creased risks.

The let­ter per­tains to two clin­i­cal in­ves­ti­ga­tions: one of which Jef­fries served as spon­sor-in­ves­ti­ga­tor for a tri­al with cataract surgery pa­tients, and the oth­er she per­formed for the drug com­pounder Im­prim­is Phar­ma­ceu­ti­cals.

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