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Executive Summary

FDA's Neuropharmacological and Metabolism & Endocrine Drug Divisions have the highest number of active INDs among FDA's nine drug review divisions, according to FDA's "Offices of Drug Evaluation: Statistical Report" for 1989. As of Dec. 31, 1989, the Division of Neuropharmacological Drugs had a total of 1,792 INDs pending, the report notes. Of those INDs, 352 were for commercial drugs. The Metabolism & Endocrine Drugs Division had the next highest level of pending INDs with 1,685. Of those submissions, 339 were for company-sponsored trials. Neuropharm also headed the IND workload in 1988. At the close of 1988, the division had 2,256 active INDs, 457 of which were for commercial products ("The Pink Sheet" Nov. 13, 1989, p. 10). The Division of Oncology and Radiopharmaceutical Drugs had the next heaviest load in 1988 with 2,157 INDs. The IND workloads are a rough barometer of the areas of highest clinical study in the U.S. If the high number of projects coming to the Neuropharm Division at FDA are an indicator, then the latter part the 1990s could develop into the decade of the brain, as it has been dubbed by the National Institute of Health. Antibiotic research remains a top commercial target. The Division of Anti-Infective Drugs had the largest amount of pending commercial INDs in 1989 and 1988. As of December 31, 1989, the division had 548 INDs pending for commercial drugs. At the end of There were 239 NDAs pending at the end of 1989: 69 of which were for new molecular entities. Out of the divisions, Cardio-Renal Drugs had the most NME applications (20) under review. Cardio-Renal also had the most NME NDAs pending (22) at the end of 1988. For 1989, the Division of Anti-Infective Drugs had the most NDAs overall with 47 applications. Of all the divisions, the Division of Anti-Infective Drugs approved the most NDAs (35) during 1989. Anti-Infectives also had the most NME approvals (five). The Division of Medical Imaging, Surgical and Dental Drugs came in second with a total of 14 NDA approvals.



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