jueves, 15 de junio de 2017

July workshop on bacteriophage therapy | New MCM monitoring & assessment resource | FDA Commissioner's Fellowhip applications open

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June 15, 2017  |  FDA Medical Countermeasures Initiative Update

T4Phage, a bacteriophage that infects E. coli bacteria. (Credit: Louisa Howard, Dartmouth)

Bacteriophage Therapy

July 10-11, 2017, Rockville, MD
Since their discovery approximately 100 years ago, bacteriophages have been investigated as a way to treat bacterial infections. In much of the world, the discovery, development, and implementation of antibiotic therapies led to a loss of interest in bacteriophages as a means to fight infections. However, in recent years, interest in this form of treatment has resurged, fueled by the increasing prevalence of antibiotic-resistant bacteria. 
The aims of the workshop are to discuss the scientific and regulatory considerations for bacteriophage therapies and to provide a forum for the exchange of information and perspectives, with the ultimate goal of facilitating development and rigorous clinical assessment of bacteriophage therapy products.
Related Information
Image: Transmission electron microscope image of T4Phage, a bacteriophage that infects Escherichia coli bacteria. (Credit: Louisa Howard, Dartmouth)

Medical countermeasure monitoring and assessment

In collaboration with the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), FDA is a key partner in developing a national capability to monitor and assess medical countermeasures (MCMs) after they are dispensed or administered in response to a chemical, biological, radiological, or nuclear threat or an emerging infectious disease.
Visit our new MCM monitoring and assessment page to learn more.
Electronic health record (Credit: CDC)

Commissioner's Fellowship Program

FDA invites outstanding healthcare professionals, scientists, and engineers to apply to our two-year Commissioner's Fellowship Program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior scientist.
  • Apply by July 7, 2017, 5:00 p.m. ET
  • Letters of recommendation are due July 20, 2017, 5:00 p.m. ET
  • Proposed projects for the Class of 2017
Students participating in the FDA Commissioner's Fellowship Program
More events
Information for industry
  • Final rule - technical amendment: FDA is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the FD&C Act as amended. (June 7, 2017)
  • The process for qualification of drug development tools (DDTs) is changing under new FD&C Act Section 507. Also see information about these updates to the DDT submission processes (June 8, 2017)
  • FDA is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on DGMPAC. Submit nomination materials by July 14, 2017.
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