Guidance with Teeth - Why the FDA Needs Enforcement Power
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Guidance with Teeth - Why the FDA Needs Enforcement Power
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In this episode of No Ordinary Subjects, host Allison Kalloo exposes a critical flaw in how clinical trials are regulated in the U.S. The FDA can issue guidance, make recommendations, and encourage diversity— but it lacks the power to enforce meaningful change. Without Congressional action, clinical trial sponsors can continue treating inclusion as optional. It’s time to demand more than suggestions. Tune in for a frank discussion on why the FDA needs real authority and what’s at stake if we keep accepting business as usual. Read the companion article on LinkedIn.
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