The VRBPAC committee will meet in open session on June 14, 2022 to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age. FDA intends to make background material available to the public no later than
The VRBPAC will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of
The VRBPAC will meet in open session on 28 June 2022 to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on
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
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,
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
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,
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
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.
