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The warning letter highlights that the firm "did not adequately evaluate the water system as a potential source of contamination, despite documented water system failures".1 Modern water systems are controlled by Programmable Logic Controllers (PLCs) and monitored by automated sensors (toc, conductivity, flow)

Compounded sterile injectables are not regulated by the FDA the same way branded medications are

There will also be increased focus on the FDA post-market review assessment of chemicals in food, which IFT weighed in on in these public comments

Why it matters: A broader mechanism does not automatically mean a safer or better treatment

Due to its relatively recent approval and higher cost, coverage may not be widespread for Wegovy