Events

Events July 18-19, 2018: Blood Products Advisory Committee public meeting (Silver Spring, MD and webcast) - The Committee will meet in open session to discuss and provide advice regarding bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. New! July 24, 2018: HHS Tick-Borne Disease Working Group meeting (webcast) - The Working Group will review and vote on the content of the five chapters that will be included in the Working Group's Report to Congress.  New! July 30-31, 2018: Continuous Manufacturing for the Modernization of Pharmaceutical Production: A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering, and Medicine's Board on Chemical Sciences and Technology, and sponsored by FDA and the Biomedical Advanced Research and Development Authority (BARDA). This workshop will discuss the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics, such as enzymes, monoclonal antibodies, and vaccines. New! 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.  New! 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! 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)