FDA has clarified several misconceptions stated in comments by stakeholders about a potential new paradigm for evaluating Rx-to-OTC switches “under conditions of safe use,” including concerns that it would create a new class of drugs.
FDA Aims To “NSURE” Clarity About New Paradigm For OTC Switches
FDA official Rikin Mehta assures stakeholders that the proposed new paradigm for Rx-to-OTC switches would not create a third class of drugs, give pharmacists prescribing power or eliminate the need for consumers to visit doctors.