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In some embodiments, the otic formulation or composition comprises between about 0.01% to about 30% by weight of the therapeutic agent, or pharmaceutically acceptable prodrug or salt thereof

Neurology 35:10571058

EMT, CSCs, and drug resistance: the mechanistic link and clinical implications

Bottom line: even if the FDA eventually recommends that certain peptides can be compounded under Section 503A, many stakeholders could still be blocked by the requirement to source pharmaceutical-grade API from an FDA-registered establishment with a Certificate of Analysis and by FDAs demonstrated willingness to police marketing claims around compounded drugs

MH received clinical trial materials and funding from Janssen Pharmaceutica NV for work related to this trial