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  1. Center for Drug Evaluation and Research | CDER

Office of Drug Evaluation IV: What We Do

The Office of New Drugs is undergoing a reorganization. This site will be updated in the near future. Please check back often. For more information, please visit Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical QualityUntil this page is updated, please use the current contact information presented on this page or contact druginfo@fda.hhs.gov if you have additional questions.

The Office of Drug Evaluation IV (ODE IV) includes three divisions: the Division of Nonprescription Drug Products (DNDP), the Division of Medical Imaging Products (DMIP) and the Division of Pediatric and Maternal Health (DPMH). The Division of Nonprescription Drug Products regulates all over-the-counter (OTC) drug products marketed in the United States to ensure that their benefits outweigh their risks, that they can be used safely in an unsupervised OTC setting, and that they are properly labeled. There are more than 80 classes (therapeutic categories) of OTC drugs available to consumers without a prescription, including more than 100,000 OTC drug products encompassing about 800 active ingredients. DNDP has been evaluating the ingredients and labeling of these products as part of the “OTC Drug Review" to establish OTC drug monographs for each class of products.

OTC drug monographs are active ingredient-based general regulations including acceptable ingredients, dosage forms, labeling, and required testing for each OTC drug class. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Updating the monographs is the primary responsibility of DNDP. Products conforming to a monograph may be marketed without FDA pre-approval, while those that do not must undergo a separate product-specific review and approval via the New Drug Application (NDA) process. The NDA process is used for new products entering the OTC marketplace for the first time, and for drugs previously available only by prescription for which appropriate data are submitted that demonstrate that they may be safely "switched" to OTC status. Scientists and regulators throughout CDER, the Office of General Counsel, and other Centers within FDA are routinely asked to assist in this massive effort. The "Nonprescription Drugs Advisory Committee" also meets regularly to assist DNDP in evaluating issues surrounding the safety and effectiveness of OTC drug products.

The Division of Medical Imaging Products is responsible for drug products used in the image-based diagnosis and monitoring of diseases. Radiology, nuclear medicine, cardiology, surgery, and various other qualified medical specialties obtain and interpret these images in their daily clinical practice. The imaging products include contrast agents used to improve the ability to see inside the body using light, x-rays, ultrasound, or magnetic resonance. Examples include the use of computed tomography to evaluate the blood circulation and to detect early cancer, stroke, or heart disease. Other imaging drug products contain small amounts of radioactivity and are used to reveal information about the structure and function of the body. Examples of  these imaging methods include positron emission tomography (PET) and single photon emission computed tomography (SPECT) for evaluating brain or heart conditions. The Division of Medical Imaging Products is also responsible for drug products used in the treatment of injury caused by radiation or radioactive materials. These treatments work by increasing the elimination of radioactive contamination from the body or by increasing the recovery of critical cells injured by radiation.

The Division of Pediatric and Maternal Health (DPMH) oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population, and improve pregnancy and lactation-related information in product labeling. The vision of DPMH is, "A world where clinically relevant data facilitate quality healthcare decisions for children and women of childbearing potential." DPMH collaborates with stakeholders both inside and outside FDA to develop clinically relevant, evidence-based labeling and other communications that facilitate informed use of medicines in children and women of childbearing potential.