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Events

• August 21-22, 2018: Public workshop - Development of Non-Traditional Therapies for Bacterial Infections (Silver Spring, MD and webcast) Discussions will focus on pre-clinical development, early stage clinical trials, and phase 3 clinical trial designs to evaluate safety and efficacy of non-traditional therapies intended to serve as primary or adjunctive therapy to existing antibacterial drugs. FDA is particularly interested in discussing pre-clinical and clinical development of several types of non-traditional therapies, including monoclonal antibodies, immunomodulators, lysins, and other non-traditional therapies. 
• August 22-23, 2018: Workshop: Exploring Medical and Public Health Preparedness for a Nuclear Incident (Washington, DC), hosted by The National Academies of Sciences, Engineering, and Medicine - Participants will explore current assumptions behind and the status of medical and public health preparedness for a nuclear incident, examine potential changes in approach, and discuss challenges and opportunities for capacity building in the current threat environment.
• 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.
• New! 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.
• New! 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 - 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. To attend, register by August 29, 2018. Also see: FDA's Predictive Toxicology Roadmap (PDF, 2.2 MB)
• New! 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! 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.