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FDA Commissioner Marty Makary stated: "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need." What this means for 503B facilities: If finalized, this proposal would permanently close the large-scale outsourcing facility compounding pathway for these three medications - regardless of future shortage conditions

For Research Use Only.

"We're looking at probably about $100 to $125, $150 a month, which is way lower than what it is right now," Tadrous said of three or more cheaper alternatives expected to come on the market in Canada

Studies are currently underway to evaluate these changes on a histologic and molecular level

Every batch goes through pharmaceutical-grade manufacturing controls, the labeling is FDA-reviewed, and the dosing matches what was studied in the original clinical trials