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Supplement Firms Have ‘Continuous Monitoring’ Burden To Show Product Safety

 
• By Malcolm Spicer

Former FDA supplement programs head Bill Frankos says the industry bears the burden for monitoring product safety in the marketplace because FDA does not have the same vested interest it has for drugs and medical devices stemming from pre-market approval of the products.

FDA does not have the same vested interest in dietary supplements it has for drugs stemming from pre-market approval of the products, leaving the industry a “greater burden” for post-market surveillance, says former FDA supplement programs head Vasilios “Bill” Frankos.

Supplement product safety monitoring can improve with manufacturers analyzing product quality complaints as comprehensively as they investigate adverse event reports,...

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