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FDA-CDC 2022 Virtual Public Workshop

Apr. 28, 2026

CDC and the Food and Drug Administration (FDA) co-sponsored a public, virtual workshop on Tuesday, August 30, 2022. The title of the workshop was Drug Development Considerations for the Prevention of Healthcare-Associated Infections (HAIs).

Topic areas

Discussions focused on the following topics:

The current state of development of pathogen-directed products used to prevent healthcare-associated infections.
Evidence supporting pathogen reduction (in patients colonized with pathogens) as a strategy to prevent infection and transmission of antimicrobial-resistant healthcare-associated pathogens.
Antimicrobial resistance threats as potential targets for decolonization and pathogen reduction.
Challenges and potential approaches to drug development and registration of products for the prevention of healthcare-associated infections.

Watch the workshop

Drug Development Considerations for the Prevention of Healthcare-Associated Infections

CDC and the Food and Drug Administration co-sponsored a public, virtual workshop on Aug. 30, 2022.

Workshop materials

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CDC & FDA Workshop Agenda

Agenda for the CDC & FDA co-sponsored virtual public workshop held on August 30, 2022.

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CDC & FDA Workshop Speaker Affiliations and Disclosures

Speaker Affiliations and Disclosures for CDC & FDA co-sponsored workshop held on August 30, 2022.

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CDC & FDA Welcome Remarks John Farley

John Farley provided welcoming remarks for the CDC & FDA co-sponsored workshop.

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CDC & FDA Workshop Session 1 Speaker Michael Craig

Michael Craig shared about prioritizing prevention and diversifying tools for patient safety.

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CDC & FDA Workshop Session 1 Speaker John Jernigan

John Jernigan shared decolonization rationale for preventing antimicrobial-resistant infections.

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CDC & FDA Workshop Session 1 Speaker Cliff McDonald

Cliff McDonald shared decolonizing approaches: current state and future needs.

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CDC & FDA Workshop Session 1 Speaker Maroya Walters

Maroya Walters spoke about multidrug-resistant gram-negative bacilli.

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CDC & FDA Workshop Session 1 Speaker Cal Ham

Cal Ham spoke about gram positives: Staphylococcus aureus and vancomycin-resistant Enterococci.

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CDC & FDA Workshop Session 1 Speaker Joe Sexton

Joe Sexton spoke about Candida auris.

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CDC & FDA Workshop Session 1 Speaker Alice Guh

Alice Guh shared on Clostridoides difficile: epidemiologic risks and decolonization strategies.

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CDC & FDA Workshop Session 1 Speaker Whitney Brown

Whitney Brown shared the impact of infection on lives of people with Cystic Fibrosis.

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CDC & FDA Workshop Session 1 Speaker Jeanine Thomas

Jeanine Thomas shared her experience with having hospital-acquired infection.

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CDC & FDA Workshop Session 2 Speaker Heidi Smith

Heidi Smith spoke about regulatory considerations for products for prevention or reduction of HAIs.

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CDC & FDA Workshop Session 2 Speaker Theresa Michele

Theresa Michele spoke on the regulation of healthcare antiseptics.

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CDC & FDA Workshop Session 2 Speaker Paul Carlson

Paul Carlson spoke on the regulatory considerations for microbiome-based therapeutics.

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CDC & FDA Workshop Session 2 Speaker Susan Huang

Susan Huang shared clinical considerations and operational challenges for prevention trails.

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CDC & FDA Workshop Session 2 Speaker Ed Bein

Ed Bein shared statistical considerations for prevention trials.

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CDC & FDA Workshop Session 2 Speaker Robert Weinstein

Robert Weinstein spoke on controlling pathogens in health care.

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CDC & FDA Workshop Session 2 Speaker James Kim

James Kim shared updates and future directions for topical antiseptics.

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CDC & FDA Workshop Session 2 Speaker Nicolas Georges

Nicholas Georges shared the development of efficacious cleaning & disinfection products in health care.

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CDC & FDA Workshop Session 2 Erin Duffy

Erin Duffy shared on considerations in the development of non-traditionals.

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CDC & FDA Workshop Session 2 Speaker Florence Sejourne

Florence Sejourne shared lessons learned developing a novel therapy to protect gut microbiota.

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CDC & FDA Workshop Session 2 Speaker Vince Wacher

Vince Wacher shared lessons learned in developing a potential point-of-care preventative for HAIs.

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CDC & FDA Workshop Session 2 Speaker Silvia Caballero

Silvia Caballero spoke about a novel approach to tackle healthcare-associated infections.

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CDC & FDA Workshop Session 2 Speaker Matt Henn

Matt Henn spoke about microbiome therapeutics to potentially transform treating resistant infections.

Formal public comments

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Michael Woodworth CDC & FDA Workshop Public Comments

Public comments on microbiome approaches to treat colonization with antibiotic-resistant bacteria.

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Carl Genberg CDC & FDA Workshop Public Comments

Public comments on preventing biofilm fouling of indwelling medical devices to reduce HAIs and AMR.

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Christopher Lehmann CDC & FDA Workshop Public Comments

Public comments on the microbiome, liver transplant, and hospital-acquired infection.

Apr. 28, 2026

Sources Print Share

Content Source:

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)