Under this paradigm, FDA would approve certain drugs that would otherwise require a prescription for nonprescription use under conditions of safe use, which would be specific to the drug and might require sale in pre-defined settings, such as a pharmacy.
FDA said the public hearing, scheduled for March 22-23 in Silver Spring, Md., is being held to obtain information and comments from the public on the feasibility of the paradigm and its potential benefits and costs.
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