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  1. How Drugs are Developed and Approved

Over-the-Counter OTC | Nonprescription Drugs

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.

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 Non-Prescription Drugs (ONPD)

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.

OTC Drugs Developed Under the OTC Drug Monograph Process

DNDP is also responsible for the development of the OTC drug monographs. Data supporting the safety and efficacy of OTC active ingredients in a particular drug monograph are reviewed by appropriate scientific personnel. Efficacy data may require the input of a Medical Officer and/or Statistician from a prescription review division. Carcinogenicity or other animal toxicology data may require input from a CDER pharmacologist. So, while DNDP is considered to be the lead division in the development of an OTC drug monograph, reviewers from multiple divisions within the Office of New Drugs (OND) may be involved in this process.

Although pre-approval by FDA for drugs marketed under a drug monograph is not required, many companies seek assurance that the product they intend to market under the drug monograph complies with the regulations. These cases are primarily handled by DNDP unless consultation with the Division of Unapproved Drugs and Labeling Compliance or another review division is necessary. If a drug cannot comply with the drug monograph, an IND and approved NDA is necessary before the drug product may be marketed.

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