Advancing FDA's medical countermeasures mission | TPOXX Drug Trial Snapshot

Events August 9, 2018: FDA Grand Rounds webcast - How Simulation Can Transform Regulatory Pathways, presented by Tina Morrison, PhD, Deputy Director, Division of Applied Mechanics, Center for Devices and Radiological Health (CDRH), FDA - 12:00 - 1:00 p.m. ET. CE credit available; please register in advance. August 13-14, 2018: Pediatric Medical Device Development public meeting (Silver Spring, MD and webcast), to identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. To attend in-person, register by 4:00 p.m. ET August 6, 2018.  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. Register by August 14, 2018. New! 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. New! 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 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 byAugust 29, 2018. Also see: FDA's Predictive Toxicology Roadmap (PDF, 2.2 MB)