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- P G Walters.
- Division of Medical Imaging, Surgical and Dental Drug Products, Food and Drug Administration, Rockville, MD 20857.
- J Public Health Dent. 1992 Jan 1; 52 (6): 333-7.
AbstractA general overview of the FDA new-drug evaluation process is presented with special emphasis on the regulatory requirements as outlined in the federal Food, Drug, and Cosmetic Act and the interpretive New Drug Regulations. Included is a description of the administrative/scientific makeup and functions of the new-drug evaluation divisions within the Center for Drug Evaluation and Research. Some specifics relating to the investigative development of anticaries and plaque/gingivitis new drug products are discussed.
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