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Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'

 
• By Malcolm Spicer

"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.

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The US Food and Drug Administration isn't expecting all Rx-to-OTC switch applications it receives will include an extra-label component to help guide consumers' self-selection, but it's ready to talk to potential switch sponsors about novel proposals.

Before focusing on developing novel switch proposals, though, firms should be certain the ingredients they're studying won't muster FDA approval for OTC distribution based only on instructions and other information stated in a Drug Facts label, says

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