Events

Events September 4, 2018: Facilitating Competition and Innovation in the Biological Products Marketplace (Silver Spring, MD) - FDA is announcing a public hearing on FDA's approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products. Electronic or written comments will be accepted after the public hearing until September 21, 2018. September 5, 2018: N95 Day 2018 Webinar: Panel Discussion of Trending Topics on Respiratory Protection, 1:00 - 2:00 p.m. ET, hosted by CDC/NIOSH - NIOSH experts will share the science behind the established guidance and recommendations. September 5-6, 2018: Medical Product Shortages during Disasters: Opportunities to Predict, Prevent, and Respond - A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering, and Medicine, and sponsored by the HHS Office of the Assistant Secretary of Preparedness and Response. To attend in-person, register in advance. September 12, 2018: Public hearing on FDA's Predictive Toxicology Roadmap (Silver Spring, MD and webcast) - FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into regulatory review, as applicable. Note: registration deadline was August 29, 2018. Also see: FDA's Predictive Toxicology Roadmap (PDF, 2.2 MB) New! September 13, 2018: FDA Grand Rounds webcast, 12:00 - 1:00 p.m. ET - Bisphenol A: Toxicology and Pharmacokinetic Data to Inform On-Going Safety Assessments, presented by K. Barry Delclos, PhD, Research Pharmacologist, Division of Biochemical Toxicology, FDA’s National Center for Toxicological Research - register in advance September 14, 2018: Public workshop - Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance (Silver Spring, MD and webcast) - To provide a forum to gather information on the latest developments in pediatric pharmacovigilance from the perspective of various stakeholders and to expand the conversation to include the utility and challenges of emerging pharmacovigilance tools, including specific challenges associated with pediatric data tools. To attend in-person or by webcast, register by September 6, 2018.  New! September 17, 2018: Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans (Rockville, MD) - Public workshop to exchange information with the scientific community about the clinical, manufacturing, and regulatory considerations associated with live microbiome-based products, when administered to prevent, treat, or cure a disease or condition in humans. Note: registration deadline was August 28, 2018. Also see: Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans New! October 3, 2018: Vaccines and Related Biological Products Advisory Committee (VRBPAC) public meeting (Silver Spring, MD and webcast) - The VRBPAC will meet in an open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 southern hemisphere influenza season. October 29-30, 2018: Save the date for BARDA Industry Day (Washington, DC) - Engage and network with members of BARDA, ASPR and other government and industry stakeholders. Registration coming soon. BARDA invites pharmaceutical companies, biotech and other innovators to present a Lightning Talk. Apply by September 7, 2018.