The agency held a public hearing on March 22-23, 2012 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.” The hearing was preliminary with no new rules passed. However, PDG’s Director of Regulatory Affairs noted that the hearing seemed to invite new approaches to current and future Rx to OTC 505(b)(2) submissions. PDG plans to update this posting with a transcript of the proceedings as soon as they are published. Meanwhile, please feel free to contact us if your company would like to learn more about Prescription to OTC switches.