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Switch Paradigm Change Sees Long Road, Breeds Questions

 
• By Malcolm Spicer

Industry has opposed establishing an intermediate class of drugs between Rx and OTC, and FDA has held it does not have authority to require firms to allow products to be approved for behind-the-counter access or some other alternative distribution. But the creation of some form of third route to access appears likely.

FDA already has a comprehensive set of questions on a “new paradigm” for nonprescription drug approvals “under conditions of safe use,” but myriad additional questions will emerge on issues ranging from approval standards and enforcement of potential restrictions to how the products are accessed by consumers.

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