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FDA ODE IV reorganization gives H. pylori reviews to new Division of Special Pathogens & Immunologic Drugs.

Executive Summary

FDA H. PYLORI THERAPY REVIEWS ASSIGNED TO DIVISION OF SPECIAL PATHOGENS and Immunologic Drug Products under a reorganization of the Office of Drug Evaluation IV. The new review division (HFD-590) was created to assume some of the workload of the Divisions of Anti-Infective Drug Products and Anti-Viral Drug Products May 12. Drug categories to be reviewed by the immunologic drugs division include drugs for non-viral opportunistic infections in AIDS patients, anti-mycobacterial drugs, solid organ transplant drugs, systemic anti-fungals including liposomal amphotericin products, vaginal anti-fungals, quinolone antibiotics not intended for ear/nose/throat indications, anti-parasitics, treatments for Helicobacter pylori, vaginal products for HIV and immunomodulating drugs, including some indications of thalidomide.



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