The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.
Date: March 22-23, 2012
Time: 9:00 a.m. to 4:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503
Silver Spring, Maryland 20993
For more information please visit: Utilizing Technologies & Other Safe Use Conditions to Expand Access to Nonprescription Drugs