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US Food and Drug Ad...
US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea
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- Hiruy, Hiwot (author)
- 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, USA
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- Bala, Shukal (author)
- 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, USA
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- Byrne, James M. (author)
- Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA
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- Roche, Kerian Grande (author)
- 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, USA
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- Jang, Seong H. (author)
- Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA
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- Kim, Peter (author)
- 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, USA
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- Nambiar, Sumathi (author)
- 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, USA
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- Rubin, Dan (author)
- Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA
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- Yasinskaya, Yuliya (author)
- 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, USA
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- Bachmann, Laura H. (author)
- 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, USA
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- Bernstein, Kyle (author)
- Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA, USA
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- Botgros, Radu (author)
- European Medicines Agency, Amsterdam, The Netherlands
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- Cammarata, Sue (author)
- Melinta Therapeutics, Parsippany, NJ, USA
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- Chaves, Ricardo L. (author)
- Debiopharm International SA, Lausanne, Switzerland
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- Deal, Carolyn D. (author)
- 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, USA
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- Drusano, George L. (author)
- Institute for Therapeutic Innovation, College of Medicine, University of Florida, Lake Nona, FL, USA
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- Duffy, Erin M. (author)
- Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University, Boston, MA, USA
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- Eakin, Ann E. (author)
- Office of Biodefense, Research Resources & Translational Research, DMID, NIAID, NIH, Bethesda, MD, USA
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- Gelone, Steve (author)
- Nabriva Therapeutics plc, Fort Washington, PA, USA
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- Hiltke, Thomas (author)
- Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Bethesda, MD, USA
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- Hook Iii, Edward W. (author)
- Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA
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- Jerse, Ann E. (author)
- Department of Microbiology and Immunology, Uniformed Services University, Bethesda, MD, USA
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- McNeil, Candice J. (author)
- 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, USA
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- Newman, Lori (author)
- Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Rockville, MD, USA
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- O'Brien, Seamus (author)
- Global Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland, USA
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- Perry, Caroline (author)
- GlaxoSmithKline, Collegeville, PA, USA
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- Reno, Hilary E. L. (author)
- Washington University School of Medicine in St. Louis, St. Louis STD/HIV Prevention Training Center, St. Louis STI Regional Response Coalition, St. Louis, MO, USA
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- Romaguera, Raul A. (author)
- Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA, USA
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- Sato, Junko (author)
- Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo, Japan
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- Unemo, Magnus, 1970- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhea and Other STIs
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- Wi, Teodora E. C. (author)
- Global HIV, Hepatitis and STIs Programmes, World Health Organization (WHO), Geneva, Switzerland
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- Workowski, Kimberly (author)
- Division of Infectious Diseases, Emory University, Atlanta, GA, USA
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- O'May, Graeme A. (author)
- DRT Strategies, Inc., 1001 19th Street N, Suite 1200, Arlington, VA, USA
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- Shukla, Sunita J. (author)
- Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA
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- Farley, John J. (author)
- Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA
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Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US. Food and Drug Administration (FDA), Silver Spring, MD, USA Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA (creator_code:org_t)
- University of Chicago Press, 2024
- 2024
- English.
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In: Clinical Infectious Diseases. - : University of Chicago Press. - 1058-4838 .- 1537-6591.
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- There is an unmet need for developing drugs for the treatment of gonorrhea, due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On April 23, 2021, the U.S. Food and Drug Administration; Centers for Disease Control and Prevention; and National Institute of Allergy and Infectious Diseases, National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of the workshop.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- Antimicrobial drugs
- antimicrobial resistance
- drug development
- gonorrhea
- unmet need
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Hiruy, Hiwot
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Bala, Shukal
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Byrne, James M.
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Roche, Kerian Gr ...
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Jang, Seong H.
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Kim, Peter
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show more...
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Nambiar, Sumathi
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Rubin, Dan
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Yasinskaya, Yuli ...
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Bachmann, Laura ...
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Bernstein, Kyle
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Botgros, Radu
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Cammarata, Sue
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Chaves, Ricardo ...
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Deal, Carolyn D.
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Drusano, George ...
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Duffy, Erin M.
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Eakin, Ann E.
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Gelone, Steve
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Hiltke, Thomas
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Hook Iii, Edward ...
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Jerse, Ann E.
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McNeil, Candice ...
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Newman, Lori
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O'Brien, Seamus
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Perry, Caroline
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Reno, Hilary E. ...
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Romaguera, Raul ...
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Sato, Junko
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Unemo, Magnus, 1 ...
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Wi, Teodora E. C ...
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Workowski, Kimbe ...
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O'May, Graeme A.
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Shukla, Sunita J ...
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Farley, John J.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmacology and ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
- Articles in the publication
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Clinical Infecti ...
- By the university
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Örebro University