Drug Development Considerations for the Prevention of Healthcare Associated Infections

The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are co-sponsoring this public virtual workshop on August 30, 2022. All meeting materials—including agenda, panelist affiliations/disclosures, speaker slides, workshop recording, and transcript—will be posted here shortly before and/or after the completion of the workshop. The current state of development of pathogen-directed

Monkeypox: Updates in Evaluation and Management

Virtual Event Virtual Event

Discuss the current landscape of Monkeypox in the U.S and infection prevention considerations for evaluation and management in healthcare settings. Describe the clinical presentation in ambulatory and inpatient settings, as well as the role of supportive and antiviral treatments. This NETEC webinar series presentation will bring together health care practitioners from Massachusetts General Hospital, Cedars-Sinai,

VRBPAC Meeting – Rebiotix Indication for Recurrent Clostridioides difficile Infection

Virtual Event Virtual Event

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene on 22 September 2022 to discuss the Biologics License Application # 125739 (BLA - 125739) from Rebiotix Inc. for a product, Rebyota (Fecal Microbiota, Live), with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for

MAQC 2022 – Massive Analysis and Quality Control Society Conference

FDA White Oak Campus 10903 New Hampshire Ave, Silver Spring, MD, United States

The 5th Annual Meeting of the FDA/National Center for Toxicological Research (NCTR) – Massive Analysis and Quality Control Society (MAQC) 2022 Conference will be held September 26-27, 2022, at the U.S. FDA Headquarters, White Oak Campus in Silver Spring MD. Conference presentations, abstracts, and discussions will include themes around: Explainable/Reproducible AI/ML, AI/ML in health-related datasets,

Study Data Standards Update for FDA CBER

Virtual Event Virtual Event

FDA's Center for Biologics Evaluation and Research (CBER)  will host a free virtual format workshop on 5 October 2022 entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission. CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) , which

Epidemics That Didn’t Happen

Virtual Event Virtual Event

Join Resolve to Save Lives for a dynamic conversation to mark the release of the second edition of “Epidemics that Didn’t Happen.” This virtual event and new report will illustrate how global and local investments in preparedness, combined with swift, strategic responses by public health authorities, can transform the trajectory of outbreaks, saving lives and preventing suffering.

Board of Scientific Counselors, National Center for Health Statistics

Virtual Event Virtual Event

The CDC has announced the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) will convene 24 October 2022 in a live broadcast public meeting. The Board is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the

Responding to the Climate Change and Health Crisis: A Framework for Academic Public Health

Virtual Event Virtual Event

The Association of Schools and Programs of Public Health (ASPPH) will host a framework launch webinar on Responding to the Climate Change and Health Crisis from 2:00 – 3:00 PM ET on Wednesday, October 26, featuring an expert panel that will discuss some of the challenges and opportunities it identifies. The framework examines climate change

Best Practices: Modeling Approaches to Support Generic Product Development

Virtual Event Virtual Event

FDA and the Center for Research on Complex Generics (CRCG) will host a free public workshop on October 27-28, 2022: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development The purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro