Development and Regulation of OTC (Nonprescription) Drug Products
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process. FDA's review of OTC drugs is primarily handled by the Center for Drug Evaluation's Office of Drug Evaluation IV.
OTC Drugs Developed Through the NDA Process
A sponsor seeking to market its product OTC, either as a new NDA or as a switch from a prescription product, applies to the Division of Nonprescription Drug Products (DNDP) in the Office of Drug Evaluation IV. DNDP will oversee drug development, including the review and regulatory action on Investigational New Drugs (INDs), and may obtain input from the specific subject matter review division (SSMRD) during the development process. After a sponsor submits an NDA, DNDP reviews the consumer studies, the post marketing safety data, the OTC labeling, and any regulatory issues. The SSMRD collaborates with DNDP (see MAPP 6020.5 Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products) and typically provides review of the efficacy and safety data related to controlled clinical trials. Additional input is obtained as needed from other disciplines outside of DNDP, including clinical pharmacology, statistics, and chemistry.
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