jueves, 30 de agosto de 2018

In case you missed it

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update







In case you missed it
  • Reminder: Professional and citizen scientists are invited to test their bioinformatics skills and software tools in a challenge to identify pathogens from the FDA-ARGOS database within host samples using NGS short-read data as part of the precisionFDA CDRH Infectious Disease NGS Diagnostics Biothreat Challenge, open now through October 4, 2018
  • FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH). Nominations received on or before October 22, 2018 will be given first consideration.
  • From DoD - Breakthrough in Malaria Prevention: USAMMDA Announces FDA Approval of New Antimalarial Drug - The U.S. Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, Maryland, announced approval by FDA for the new antimalarial drug, tafenoquine (Arakoda). The new drug application for Arakoda, submitted by 60° Pharmaceuticals (60P) in partnership with the U.S. Army Medical Research and Materiel Command, received approval for the prevention of malaria, following priority review. This is the first new FDA-approved prophylactic drug for malaria in over 18 years. Tafenoquine (Arakoda) is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. Also see: approval letter (PDF, 43 KB) and product label (PDF, 278 KB) (August 10, 2018)
  • From HHS ASPR - BARDA and its partners bring new ammunition to the battle against superbugs - Since 2010, BARDA has worked with 12 private companies on developing 15 new antibiotics, and already three have earned approval by the FDA. These approvals, among the 40 approvals of BARDA-sponsored medical countermeasures, mark critical milestones in our nation’s health security preparedness. (August 27, 2018)
  • From NIH - NIH begins clinical trial of live, attenuated Zika vaccine - Vaccinations have begun in a first-in-human trial of an experimental live, attenuated Zika virus vaccine, known as rZIKV/D4Δ30-713, which was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. (August 16, 2018)
  • You want to make a difference. FDA wants to hire you. Follow @FDAJobs on Twitter, or visitwww.fda.gov/jobs.

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