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PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS

Advances in drug, biologic, and medical device development deal with both single entities and combinations of each type of medical product. A desire for new modes of administration of therapeutics, enhancement of long-term delivery of drugs and biologics, new routes of administration, and commercial/competitive reasons have led to a veritable explosion of requests for review of experimental combination products. These developments continue to be enhanced by advances in technology and materials science, as well as biotechnological sophistication of manufacturing processes. All of these factors have generated requests for the FDA to review combination investigational drug and device applications for human clinical testing. Eventually, these programs will lead to NDAs for marketing approval, where a drug is involved.