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Antimicrobial Resistance Information from FDA

Image
Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. Credit: NIAID
Caption
Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. (Credit: NIAID)

On this page:
What's new | The FDA's role and strategic approach | Product development | Antimicrobial stewardship | Surveillance and monitoring | Regulatory science | FDA publications | Information for consumers | Press and statements | Events | Interagency collaboration | Contact the FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem.

According to the Centers for Disease Control and Prevention (PDF, 148 pages), each year in the United States at least 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a result. Combating AMR requires multifaceted efforts in both the healthcare and veterinary sectors.

What's new

The FDA's role and strategic approach

Antimicrobial resistance is recognized as a growing global threat. In 2014, the White House announced the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), underscoring the need for a coordinated inter-agency response to this threat. The FDA has been and continues to be integral in these efforts.

Several of FDA’s Centers—including the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), and the Office of the Chief Scientist—play key roles in combating AMR. 

The FDA is dedicated to addressing the challenges AMR presents by helping to preserve the effectiveness of currently available antimicrobial drugs and promoting the development of new medical products that can help reduce the emergence and spread of AMR bacteria.

Working with both domestic and international partners, the FDA is proactively addressing the complex challenges associated with the growing threat of AMR by:

  • Facilitating efficient product development to address AMR, including the development of new antimicrobials, diagnostic tests, and vaccines
  • Promoting the appropriate and responsible use of antimicrobials and disseminating information promoting interventions that help slow the development of resistance
  • Supporting the development and enhancement of tools for conducting surveillance of antimicrobial use and resistance so stakeholders can better track, treat, or respond to AMR outbreaks
  • Advancing regulatory science to develop the tools, standards, and approaches to facilitate the translation of breakthrough discoveries in science and technology into innovative, safe, and effective medical products

To achieve this mission, the FDA will continue to work collaboratively with Congress, its partners at other U.S. government agencies, and other stakeholders to find additional ways to prevent, detect, and address AMR.

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Product development

The FDA works closely with product sponsors and other government agencies to facilitate efficient product development to address AMR, including new antimicrobial drugs, biologics (including human vaccines), and diagnostics. 

  • The FDA employs a variety of mechanisms, where appropriate, to help speed the development and availability of medical products for humans: Fast track designation, priority review, and breakthrough therapy designation.
  • Under Generating Antibiotic Incentives Now (Report to Congress; PDF, 545 KB), or GAIN, the FDA is authorized to provide a five-year extension of exclusivity to incentivize the development of new Qualified infectious disease products (QIDPs) (PDF, 390 KB). A QIDP is defined as “an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen.” As of August 2018, the FDA has approved 15 new QIDPs for bacterial or fungal infections.
  • Established by Congress under the 21st Century Cures Act, the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, is a new step to help advance development of  antimicrobial drugs for limited populations of patients with unmet need. 
  • Experts from the FDA’s Center for Biologics Evaluation and Research provide advice to academic investigators and sponsors through the Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT), which can help streamline product development and approval.
  • The FDA is also in discussion with other agencies including the Centers for Medicare and Medicaid Services (CMS) to explore the means for reimbursement of certain new antibacterial drugs that meet critical patient and public health needs.  

The FDA is working to advance the development of nontraditional antimicrobial products including:

The FDA is also working to advance the development of vaccines for organisms contributing to AMR.

FDA encourages the development of novel in vitro diagnostic (IVD) devices for detection of AMR associated with microbial pathogens.

When searching for AMR-related device approvals it is helpful to know the associated Product Code for the class of AMR-related devices.

  • You can find these codes in the CDRH Product Classification database, by searching for the terms susceptibility, antimicrobial, or resistance in the “device” section.
  • While not a complete list, examples of Product Codes associated with AMR-related device approvals include: JTN, JWY, LON, LTT, LRG, LTW, PEN, PAM, and POC.
  • These Product Codes include phenotypic antimicrobial susceptibility test (AST) devices and devices that determine AMR by other means, such as genetic markers. (FDA maintains a list of cleared or approved Microbial Nucleic Acid Devices; please note that this list also includes other devices that do not detect genetic markers of resistance.)
  • Knowing the Product Code also makes it easier to find specific AMR-related device approvals when searching the PMA, de novo, and 510(k) databases.

Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include:

  • December 20, 2021: FDA cleared the Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Cefiderocol in the Dilution Range of 0.03-64 µg/mL (K203741), a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of Cefiderocol with additional indicated species (Acinetobacter baumannii and Serratia marcescens) and using updated breakpoints for members of the Enterobacterales order.

  • December 15, 2021: FDA cleared the Sensititre YeastOne Susceptibility System with Voriconazole in the Dilution Range of 0.008 - 8 μg/mL (K211539), a micro-version of the broth dilution susceptibility test performed in multi-well microtiter plates to determine the minimum inhibitory concentration of voriconazole, an antifungal agent with new breakpoints and indications for testing Candida species.

  • November 12, 2021: FDA cleared the ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757), a gradient diffusion assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.

  • October 28, 2021: FDA cleared the APAS Independence with IC Chromogenic MRSA BD Analysis Module and the APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839), an in vitro diagnostic test system for the automated assessment of microbial colonies on chromogenic culture media to aid in screening for methicillin-resistant Staphylococcus aureus (MRSA).

  • October 28, 2021: FDA cleared the VITEK 2 AST- Streptococcus Cefotaxime (≤0.125 - ≥8 µg/mL) (K210287), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Cefotaxime with Streptococcus species.

  • October 27, 2021: FDA cleared the Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873), a disk diffusion assay for in vitro susceptibility testing of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia. 

  • October 20, 2021: FDA cleared the MTS Piperacillin-Tazobactam 0.016/4 - 256/4 µg/mL (K211672), a gradient diffusion assay to determine the minimum inhibitory concentration of Piperacillin-Tazobactam, a combination antibiotic that is used to treat various bacterial infections.

  • September 30, 2021: FDA cleared the Acuitas AMR Gene Panel (K191288), a qualitative nucleic acid-based, highly multiplexed in vitro diagnostic test for the simultaneous detection and identification of 28 genetic determinants of resistance to 8 antibiotic groups (aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, sulfonamides, trimethoprim, vancomycin) among 19 organism species for a total of 117 unique organism/gene combinations being reported. The Acuitas AMR Gene Panel includes an extension of the device labeling (electronic user guide) that provides additional supporting information about performance characteristics and interpretation of genetic determinants associated with antimicrobial resistance for the Acuitas AMR Gene Panel.
  • September 14, 2021: FDA cleared the VITEK 2 AST-Gram Positive Fosfomycin (≤8 - ≥256 µg/mL) (K202396), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.
  • July 30, 2021: FDA cleared the Thermo Scientific Oxoid Cefiderocol Disc (30ug) FDC30 (K203700), a disk diffusion assay for in vitro susceptibility testing of Cefiderocol, a newer antibiotic for the treatment of complicated urinary tract infection.
  • July 23, 2021: FDA cleared the Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Autoread Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) (K202612), a miniaturized version of the classic broth dilution method that can provide both qualitative and quantitative susceptibility results from Haemophilus influenza, Streptococcus pneumoniae and Streptococcus species when tested with erythromycin or clindamycin. The Dtest detects for inducible clindamycin resistance in Streptococcus spp. resistant to erythromycin.
  • July 9, 2021: FDA cleared the VITEK 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 µg/mL) (K201675), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated interpretive criteria. 

  • June 14, 2021: FDA cleared the VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 µg/mL) (K211136), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam. A claim was added to the previously cleared device to include a new indicated species, Acinetobacter calcoaceticus-baumannii complex.

  • May 27, 2021: FDA cleared the MicroScan MICroSTREP Plus Panels With Tetracycline (0.06-16 µg/mL) (K202423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Tetracycline with aerobic streptococci. Performance data was updated to include reanalysis of MIC results for Streptococcus pneumoniae with tetracycline using currently recognized interpretive criteria.

  • November 16, 2020:  MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 μg/mL) (K202343), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections

  • September 28, 2020: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/mL) (K193299) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections.

  • September 15, 2020: Accelerate Pheno System, Accelerate PhenoTest BC Kit  (K192665) a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative antimicrobial susceptibility methods directly from positive blood culture samples. Claims were added for antimicrobial susceptibility testing of Pseudomonas aeruginosa with ceftazidime, cefepime, meropenem, piperacillin/tazobactam, and aztreonam. 

  • June 29, 2020: Addition of Acinetobacter spp. for testing with the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004 - 32 µg/mL) (K201423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated the susceptibility test interpretive criteria on the STIC website to include interpretive criteria when testing this organism group.

  • May 7, 2020: ETEST Plazomicin (0.016 - 256 µg/mL) (K200512) a gradient diffusion assay to determine the minimum inhibitory concentration of Plazomicin, an antibiotic for the treatment of complicated urinary tract infection

  • April 28, 2020: VITEK 2 AST-Gram Positive Delafloxacin (≤0.015 - ≥1 µg/mL) (K200590) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Delafloxacin, an antibiotic approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)

  • April 6, 2020: MTS Lefamulin 0.016 - 256 µg/mL (K200308) a gradient diffusion assay to determine the minimum inhibitory concentration of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.

  • March 20, 2020: MTS Omadacycline 0.002 - 32 µg/mL (K200180) a gradient diffusion assay to determine the minimum inhibitory concentration of Omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

  • March 18, 2020: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8 µg/mL) (K193536) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ciprofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.

  • March 18, 2020: BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) a multiplexed nucleic acid-based test for the detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance direct from positive blood culture samples.

  • March 13, 2020: VITEK 2 AST-Gram Negative Imipenem/Relebactam (≤0.25/4 - ≥16/4 µg/mL) (K193572) abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam, an antibiotic approved eight months ago for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.

  • March 12, 2020: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mL (K193538) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration Cefiderocol, an antibiotic approved four months ago for the treatment of complicated urinary tract infections.
  • March 3, 2020: MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008 - 16 µg/mL) (K193358) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Levofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.
  • January 8, 2020: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus Pneumoniae MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008 – 16 µg/mL (K193024) a broth-microdilution assay that was cleared shortly after new drug approval for Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.
  • January 23, 2020: HardyDisk AST Cefiderocol 30µg (FDC30) (K193504) a disk diffusion assay that was the first AST device for Cefiderocol, an antibiotic for the treatment of complicated urinary tract infection. This device was cleared just eight weeks after new drug approval.
  • December 20, 2019: FDA recently cleared the Unyvero LRT BAL Application (K191967), a multiplex molecular test for the detection and identification of nucleic acid sequences from 20 bacterial/fungal pathogens and 10 antibiotic resistance markers to aid in the diagnosis of pneumonia. It is the first multiplexed pneumonia panel that identifies Pneumocystis jirovecii, a leading cause of pneumonia in immunocompromised patients.
  • December 5, 2019: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria - FDA authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.
  • November 26, 2019: FDA cleared the AST device bioMerieux ETEST Delafloxacin (DFX) 0.002-32 μg/mL (K192738) a gradient diffusion assay for testing Delafloxacin
  • November 14, 2019: FDA cleared the AST device MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K192355) a broth-microdilution assay for testing Meropenem.
  • November 6, 2019: FDA recently cleared AST devices for testing newly approved antimicrobial agents:
  • October 31, 2019: FDA cleared the AST device MTS Ampicillin-Sulbactam 0.016/0.008 – 256/128 µg/mL (K192345) a gradient diffusion assay for testing Ampicillin-Sulbactam.
  • October 2, 2019: FDA cleared NG Test CARBA 5 (K191889), the first rapid lateral flow immunochromatographic assay that detects and differentiates between five common types of carbapenemase enzymes (KPC, OXA, NDM, VIM, IMP). The assay tests pure colonies after growth on solid media, with results obtained in 15 minutes. The test is intended as an aid infection control.
  • September 25, 2019: FDA cleared ARIES MRSA assay (K191742), another nucleic acid amplification test (NAAT) for MRSA detection from nasal swabs. This and similar assays are used as an aid in the prevention and control of MRSA infections in healthcare settings.

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Antimicrobial stewardship

The FDA works closely with domestic and international partners to promote the judicious use of antibiotics in the veterinary setting and complements the work done by other government agencies in the human healthcare setting.

On the veterinary side, the FDA’s Center for Veterinary Medicine (CVM) is responsible for:

  • Ensuring that animal drugs are safe and effective for their approved conditions of use, and
  • Playing an active role in coordinating the development and implementation of regulations and policies pertaining to antimicrobial drugs intended for use in animals, including food-producing animals.

CVM’s activities to advance antimicrobial stewardship are further detailed in CVM’s plan, Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 (PDF, 282 KB). Also see: FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings

On the human healthcare side, the FDA supports policies and regulations designed to preserve the effectiveness of antimicrobials for human use. This includes:

  • Working to ensure the labeling of antimicrobial drugs intended for use in humans contain required statements regarding appropriate use
  • Providing recommendations on scientifically sound clinical trial designs to evaluate human drugs to help inform appropriate use and stewardship efforts
  • Maintaining the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria webpage
  • Working with diagnostic manufacturers and academia on developing biomarkers to rapidly identify whether a patient’s symptoms are due to a bacterial infection, or when antibiotics can be stopped during treatment
  • Promoting flexible regulatory approaches to rapid identification of bacterial pathogens, thereby allowing targeted antibiotic treatment and reducing broad-spectrum antibiotic use

Also see from CDER: Combating Antibiotic Resistance

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Surveillance and monitoring of antimicrobial use and resistance

The FDA works in close coordination with interagency partners and domestic stakeholders to collect the data necessary to conduct surveillance and monitoring of antimicrobial use and resistance.

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Regulatory science

The FDA supports regulatory science to develop the tools, standards, and approaches to facilitate the translation of breakthrough discoveries in science and technology into innovative, safe, and effective medical products.

The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Antimicrobial resistance is a priority area, under the focus area “Public Health Preparedness and Response.” Please contact [email protected] with questions about this initiative.

Tools for scientists

Community stakeholders: We need your samples

As part of our effort to address the global health challenge of AMR, FDA supports the development of next-generation sequencing (NGS)-based diagnostics to help healthcare providers identify and treat the right pathogen. To help build NGS infrastructure, our FDA-ARGOS database makes publicly available quality-controlled microbial reference genomes for diagnostic use. The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens, and AMR-related pathogens to help improve the database. We encourage the community to share microbe samples.

Image: A lab worker in the CDC-FDA AR Isolate Bank (Credit: CDC)

The Center for Drug Evaluation and Research

  • CDER's Office of Antimicrobial Products research activities include facilitating the development of new antibacterial drugs to treat patients and advancing the science of clinical trial design.

  • Exploiting Real-World Data to Optimize the Use of Antibiotics - Through the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) (PDF, 370KB - research summary published Nov. 2021), FDA's Center for Drug Evaluation and Research (CDER) has supported research at Johns Hopkins University School of Medicine to help us use the data in electronic health records to better understand the association between varying durations of antibiotic therapy and patient outcomes. These two research studies demonstrated the feasibility and advantages of a novel automated approach for extracting patient-level data from electronic health records to capture treatment outcomes in diverse real-world health care settings. The results provide valuable evidence to inform best practices related to the duration of antibiotic treatment in diverse bacterial infections, optimizing patient outcomes while reducing the risk for antimicrobial resistance.

The Center for Biologics and Evaluation and Research

The National Center for Toxicological Research’s Microbiology Division

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FDA publications

Guidance documents, compliance policy guides, and other FDA publications represent the FDA's current thinking on a topic. Documents related to antimicrobial resistance in humans and animals include guidances on developing products for treatment, prevention, and diagnosis of bacterial infections. You can also find information for the animal and veterinary industry on collection of sales and distribution of antimicrobial products, and veterinary feed directives.

You can search the entire database of FDA guidance documents by keyword, or visit the industry pages below for more information.

For information about FDA-recognized antimicrobial susceptibility test interpretive criteria, visit http://www.fda.gov/STIC, and the corresponding Notice of Updates.

  • 510(k) Premarket Notification and de novo databases – provide information on all in vitro diagnostic devices cleared or granted since November 2003, including devices that detect antibiotic resistance markers, phenotypic antimicrobial susceptibility devices, and biomarkers used to aid in patient management
  • Part of FDA's strategic approach for combatting antimicrobial resistance involves providing guidance that aims to facilitate the availability of antimicrobial susceptibility tests in a timely manner once a new antibacterial drug is approved. On January 17, 2019, FDA published a new guidance for industry, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (PDF, 438 KB). The goal of this guidance is to minimize time between the approval of new antimicrobial drugs and clearance of antimicrobial susceptibility tests used to determine the potential effectiveness of those drugs; and provide recommendations to the medical device and drug industries on how to work together to facilitate timely clearance of antimicrobial susceptibility test devices by the FDA. FDA will discuss this final guidance at a webinar scheduled for February 12, 2019. (Federal Register notice)

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Information for consumers

FDA consumer updates

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Press and statements

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Events

The following is a list of select recent and upcoming AMR-related events involving the FDA.

  • October 7, 2021: The Antimicrobial Drugs Advisory Committee will meet via webcast. The committee will discuss new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. (Federal Register notice)
  • August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy workshop (virtual) - FDA's Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID) are hosting a public workshop to exchange information with the medical and scientific community about the regulatory and scientific issues associated with bacteriophage therapy.
  • April 23, 2021: Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea (virtual workshop), hosted by FDA, NIAID, and CDC to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea. 

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Interagency collaboration to address AMR

FDA participates in and contributes to Combating Antibiotic-Resistant Bacteria (CARB), a Government-wide effort launched in 2014, including the work of:

FDA’s Office of Public Health Strategy and Analysis (OPHSA) coordinates FDA’s involvement in CARB and represents FDA on PACCARB.  Based on consultation with and input from FDA’s Centers, OPHSA routinely updates HHS on FDA’s progress in meeting National Action Plan goals, objectives, and milestones. 

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Contact the FDA

Consumers and general information: contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)

Report a fraudulent product
Includes options for phone and online reporting

Press: contact the Office of Media Affairs
Email [email protected] or call 301-796-4540

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