FDA Considers New Paradigm for Approval of Certain Drugs as OTC

February 29, 2012 11:27 am Topics: Federal regulations

FDA will hold a public hearing on a new paradigm the agency is considering for approval of certain drugs that would otherwise require a prescription, as over-the-counter medications under conditions of safe use. FDA explains that these conditions of safe use would be specific to the drug product and might require sale in certain pre-defined health care settings, such as a pharmacy. The public hearing will be held on March 22 and 23, 2012, from 9 AM to 4 PM at FDA's White Oak Campus in Silver Spring, MD to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs. Electronic or written requests for oral presentations and comments may be submitted by March 9, 2012. Additional information on the meeting is available on the FDA Web site.