PDG to attend FDA’s OTC Public Hearing

The agency recently announced 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.” Please let us know if you plan to attend…

Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced

According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the-counter (OTC) drug monograph system and to describe the process for submitting that  information. FDA regulations set forth criteria and procedures by which…