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Making Progress On Novel OTC Switch Rulemaking Has FDA Commissioner Nominee Califf’s Attention

 
• By Malcolm Spicer

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

Robert Califf in fornt of FDA building
• Source: FDA images combined

Robert Califf’s likely confirmation by the Senate would send him to the Food and Drug Administration commissioner post with him “mindful” that modernizing the agency’s Rx-to-OTC switch paradigm has been a regulatory goal for a decade.

Califf, who previously was commissioner for 11 months ending in January 2017, answered Health, Education, Labor and Pensions Committee members...

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