martes, 28 de febrero de 2017

February 27, 2017 | FDA Medical Countermeasures Initiative Update

New FDA Logo Blue

February 27, 2017  |  FDA Medical Countermeasures Initiative Update

Organ-on-chip (Image: Wyss Institute for Biologically Inspired Engineering)

New funding opportunity (BAA)

To help develop solutions to complex regulatory science challenges, FDA funds medical countermeasure (MCM)-related research through intramural and extramural research grants.
Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation, under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security.
The current BAA announcement was posted on February 23, 2017, and will remain open until further notice.
Related Information
Image: Organ-on-a-chip held between thumb and forefinger. In one ongoing FDA BAA project, Harvard University's Wyss Institute for Biologically Inspired Engineering is testing candidate radiation MCMs using novel organs-on-chips technology. (Credit: Wyss)

New public workshop - March 1, 2017

Silver Spring, MD and webcast
FDA is conducting this workshop to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. When the species occurs infrequently, performing clinical trials can be extremely challenging. Therefore, animal models of infection may be useful to explore the activity of a candidate antibacterial drug and may help to predict whether the drug will be efficacious in humans.
Pseudomonas aeruginosa bacteria (CDC)
  • March 8-9, 2017: Examining Opportunities for the Future of Medical and Public Health Preparedness: A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
  • March 9, 2017: Vaccines and Related Biological Products Advisory Committee (Rockville, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
  • New! March 14-17, 2017: FDA/Xavier University PharmaLink conference Increasing Product Confidence (Cincinnati, OH) - the conference will engage those involved in FDA-regulated global supply chain quality and management (fee)
  • New! March 21-22, 2017: Free Emerging Infectious Disease Preparedness Training  (Omaha, NE), for healthcare workers and public health officials, hosted by CDC and the National Ebola Training & Education Center (more training dates/registration info)
  • New! April 3-4, 2017: Free Emerging Infectious Disease Preparedness Simulation Training  (New York, NY), for clinicians, hosted by CDC and the National Ebola Training & Education Center
  • April 6, 2017: Public workshop - Emerging Tick-Borne Diseases and Blood Safety(Bethesda, MD) - to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions - register by March 23, 2017
  • New! April 24-26, 2017: 20th Annual Conference on Vaccine Research  (Bethesda, MD), hosted by the National Foundation for Infectious Diseases - includes presentations on development and approval pathways of vaccines to prevent infectious diseases (FDA's Marion Gruber, PhD, is presenting), and evaluating vaccine safety during public health emergencies (fee)
  • April 25-28, 2017: Preparedness Summit  (Atlanta, GA) - FDA's Gregory Measer, JD, will present Beyond the Last Mile: Monitoring and Assessing Medical Countermeasure Use in Response to Public Health Emergencies (fee)
  • New - save the date! May 31 - June 1, 2017: FDA Science Forum (Silver Spring, MD) - The Forum will highlight the breadth and depth of cutting-edge science FDA conducts and will demonstrate how FDA's scientific research informs our regulatory decision-making.
In case you missed it
Course instructor assists student during FDA UTMB data quality course
  • From NIH - NIH Begins Study of Vaccine to Protect Against Mosquito-Borne Diseases - NIAID has launched a Phase 1 clinical trial to test an investigational vaccine intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections. (February 21, 2017)
  • From NIAID - Cellular Therapies for Treatment of Radiation Injuries - The purpose of this Funding Opportunity Announcement (FOA) is to support studies to evaluate candidate cellular therapies to treat radiation-induced injuries in appropriate in vivo models when administered 24 hours or more post-irradiation. Letters of intent due July 1, 2017.
  • The National Institute for Occupational Safety and Health (NIOSH) of the CDC announced the availability of a draft web-based database entitled PPE-Info for public comment. The PPE-Info Database serves as a compendium of Federal regulations and consensus standards for Personal Protective Equipment (PPE). Comment by April 13, 2017.
  • Did you know... FDA scientists invent. 32 patents issued in 2016.

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