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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

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
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
Byrne, James M. (author)
Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA
show more...
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
Jang, Seong H. (author)
Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA
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
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
Rubin, Dan (author)
Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, MD, USA
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
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
Bernstein, Kyle (author)
Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA, USA
Botgros, Radu (author)
European Medicines Agency, Amsterdam, The Netherlands
Cammarata, Sue (author)
Melinta Therapeutics, Parsippany, NJ, USA
Chaves, Ricardo L. (author)
Debiopharm International SA, Lausanne, Switzerland
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
Drusano, George L. (author)
Institute for Therapeutic Innovation, College of Medicine, University of Florida, Lake Nona, FL, USA
Duffy, Erin M. (author)
Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University, Boston, MA, USA
Eakin, Ann E. (author)
Office of Biodefense, Research Resources & Translational Research, DMID, NIAID, NIH, Bethesda, MD, USA
Gelone, Steve (author)
Nabriva Therapeutics plc, Fort Washington, PA, USA
Hiltke, Thomas (author)
Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Bethesda, MD, USA
Hook Iii, Edward W. (author)
Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA
Jerse, Ann E. (author)
Department of Microbiology and Immunology, Uniformed Services University, Bethesda, MD, USA
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
Newman, Lori (author)
Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH, Rockville, MD, USA
O'Brien, Seamus (author)
Global Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland, USA
Perry, Caroline (author)
GlaxoSmithKline, Collegeville, PA, USA
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
Romaguera, Raul A. (author)
Division of STD Prevention, NCHHSTP, CDC, Atlanta, GA, USA
Sato, Junko (author)
Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo, Japan
Unemo, Magnus, 1970- (author)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhea and Other STIs
Wi, Teodora E. C. (author)
Global HIV, Hepatitis and STIs Programmes, World Health Organization (WHO), Geneva, Switzerland
Workowski, Kimberly (author)
Division of Infectious Diseases, Emory University, Atlanta, GA, USA
O'May, Graeme A. (author)
DRT Strategies, Inc., 1001 19th Street N, Suite 1200, Arlington, VA, USA
Shukla, Sunita J. (author)
Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, MD, USA
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.
In: Clinical Infectious Diseases. - : University of Chicago Press. - 1058-4838 .- 1537-6591.
  • Journal article (peer-reviewed)
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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