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  • VRBPAC Meeting – Rebiotix Indication for Recurrent Clostridioides difficile Infection

    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

  • Navigating Avian Influenza: From Prevention to Recovery

    Virtual Event

    Hear insights and information from APHIS and other experts on steps to take and what to expect during a bird flu outbreak during a free webinar on 22 September 2022. Learn from USDA and other experts about how to keep your flocks safe from highly pathogenic avian influenza (HPAI). This session is for enthusiasts, farmers,

  • 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,

  • IARPA PICARD Program Proposers’ Day

    Ballston Metro Station Arlington, VA, United States

    The IARPA Pursuing Intelligent Complex Aerosols for Rapid Detection (PICARD) program will host a Proposer's Day on 26 September 2022 to introduce the PICARD program to potential proposers and to provide information on technical requirements and program objectives. The PICARD program intends to develop a fieldable sensing platform for the rapid identification of aerosol particles

  • GBHI 2022 – 5th Annual Global Bioequivalence Harmonization Initiative Meeting

    Virtual Event

    The goal of the Global Bioequivalence Harmonization Initiative (GBHI) conference is to offer the most informative and up to date science and regulation of bioequivalence in global drug development. The FDA AAPS EUFEPS 5th Annual GBHI Meeting will be held 28-29 September 2022. GBHI workshop provides an open forum for pharmaceutical scientists from academia, industry

  • National Biodefense Science Board Public Meeting

    Virtual Event

    The next public meeting of the National Biodefense Science Board (NBSB) will take place on Thursday, September 29. Join NBSB members, distinguished guests, federal leaders, and subject matter experts exploring topics such as how best to support rural and underserved communities during the COVID-19 pandemic, use of virtual healthcare during disasters, and health system operational

  • Study Data Standards Update for FDA CBER

    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

  • VRBPAC Meeting – Vaccine Strain Selection 2023 Southern Hemisphere Flu Season

    Virtual Event

    The FDA Vaccines and Related Biological Products Advisory Committee will convene on 6 October 2022 in open session to discuss the Strain Selection for the Influenza Virus Vaccines for the 2023 Southern Hemisphere Influenza Season. Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. Interested

  • FDA NanoDay Symposium 2022

    Virtual Event

    The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. Highlighted topic areas include: Primary Chemistry Manufacturing and