PDG to attend FDA’s OTC Public Hearing

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

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

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

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…