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

In case you missed it

• Drug shortages update: Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities (July 19, 2018)
• Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET) - A new OCET-sponsored project to explore how the Sentinel System may inform study protocols for MCM safety and effectiveness has been added to the Sentinel website. This project will also provide a baseline for comparison during a public health emergency. Also see Medical Countermeasure Monitoring and Assessment (July 18, 2018)
• FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Send a letter or email stating interest by August 29, 2018. 
• From NIH - Tickborne diseases are likely to increase, say NIH officials - The incidence of tickborne infections in the United States has risen significantly within the past decade. It is imperative, therefore, that public health officials and scientists build a robust understanding of pathogenesis, design improved diagnostics, and develop preventive vaccines, according to a new commentary in the New England Journal of Medicine from leading scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). (July 25, 2018)
• From NIH - Broadly acting antibodies found in plasma of Ebola survivors - Scientists supported by NIAID have discovered a set of powerful, broadly neutralizing antibodies (bNAbs) in the blood of Ebola virus disease survivors. In animal studies, two of these antibodies provided substantial protection against disease caused by Zaire ebolavirus, Bundibugyo ebolavirus and Sudan ebolavirus, the three species known to cause fatal human illness. (July 17, 2018)
• You want to make a difference. FDA wants to hire you. Follow @FDAJobs on Twitter, or visitwww.fda.gov/jobs.