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FDA, CDC, and NIH Co-sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.

Autor: Hiruy H; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD., Bala S; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD., Byrne JM; Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD., Roche KG; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD., Jang SH; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, MD., Kim P; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD., Nambiar S; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD., Rubin D; Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD., Yasinskaya Y; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD., Bachmann LH; Division of STD Prevention, National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC), Atlanta, GA., Bernstein K; Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA., Botgros R; European Medicines Agency, Amsterdam, The Netherlands., Cammarata S; Melinta Therapeutics, Parsippany, NJ., Chaves RL; Debiopharm International SA, Lausanne, Switzerland., Deal CD; Enteric and Sexually Transmitted Infections Branch, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD., Drusano GL; Institute for Therapeutic Innovation, College of Medicine, University of Florida, Lake Nona, FL., Duffy EM; Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University, Boston, MA., Eakin AE; Office of Biodefense, Research Resources & Translational Research, DMID, NIAID, NIH, Bethesda, MD., Gelone S; Nabriva Therapeutics plc, Fort Washington, PA., Hiltke T; Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Bethesda, MD., Hook Iii EW; Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL., Jerse AE; Department of Microbiology and Immunology, Uniformed Services University, Bethesda, MD., McNeil CJ; Department of Medicine, Section on Infectious Diseases, Wake Forest University School of Medicine, Southeast STD/HIV PTC, Forsyth County Department of Public Health, and North Carolina Strengthening the United States Response to Resistant Gonorrhea, Winston-Salem, NC., Newman L; Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Rockville, MD., O'Brien S; Global Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland., Perry C; GlaxoSmithKline, Collegeville, PA., Reno HEL; Washington University School of Medicine in St. Louis, St. Louis STD/HIV Prevention Training Center, St. Louis STI Regional Response Coalition, St. Louis, MO., Romaguera RA; Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA., Sato J; Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo, Japan., Unemo M; WHO Collaborating Centre for Gonorrhea and Other STIs, Örebro University, Örebro, Sweden., Wi TEC; Global HIV, Hepatitis and STIs Programmes, World Health Organization (WHO), Geneva, Switzerland., Workowski K; Division of Infectious Diseases, Emory University, Atlanta, GA., O'May GA; DRT Strategies, Inc., 1001 19th Street N, Suite 1200, Arlington, VA., Shukla SJ; Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD., Farley JJ; Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD.

Publikováno v: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 Jul 24. Date of Electronic Publication: 2024 Jul 24.