miércoles, 30 de marzo de 2016

FDA allows use of investigational test to screen blood donations for Zika virus

FDA Medical Countermeasures 

Initiative Update

FDA allows use of investigational 

test to screen blood donations for 

Zika virus

An FDA scientist collects plasma from processed whole blood (FDA - Michael J. Ermarth)

Use of investigational test allows blood establishments in Puerto Rico to resume collecting both Whole Blood and blood component donations

March 30, 2016 - FDA today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

Read the press release 

Related information

Image: Jason Liu, PhD, a laboratory chief at FDA’s Office of Blood Research and Review, collects plasma from processed whole blood. FDA is responsible for the safety of our nation’s blood supply and is at the forefront of evaluating and encouraging innovative technologies for protecting it. (FDA photo by Michael J. Ermarth)

FDA approves new treatment for inhalation anthrax

On March 18, 2016, FDA approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. It is caused by breathing in the spores of the bacterium Bacillus anthracis. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.

Anthrax is a potential bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air.

Read the press release

Related information

Zika-related FDA guidance issued to date

News updates

  • April 19-22, 2016: Preparedness Summit disclaimer icon (Dallas, TX), hosted by the National Association of County and City Health Officials (NACCHO) (fee) - includes a Medical Countermeasures Link workshop disclaimer icon to provide federal updates for state strategic national stockpile and local MCM coordinators 
  • Updated! April 25-29, 2016: Achieving Data Quality and Integrity in Maximum Containment Laboratories course (Bethesda, MD), hosted by FDA and the University of Texas Medical Branch - Galveston National Laboratory - the course covers how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level laboratory facilities (BSL-4). Registration deadline extended! Follow registration instructions by noon on April 4, 2016 if interested in attending.
View more events on the frequently updated MCMi News and Events page
Emergency Use Authorization (EUA) updates:
More information and all current EUAs
Funding opportunities and deadline reminders:
  • NIH posted a Funding Opportunity Announcement to provide an expedited funding mechanism for research on Zika virus and its complications. Applications will be accepted on a rolling basis, beginning on April 20, 2016.
  • The CDC Office of Public Health Preparedness and Response (OPHPR) has posted a Broad Agency Announcement (BAA) open for concept paper submission until April 25, 2016. The aim of this funding is to support innovative research to improve the ability of CDC and its partners, including state and local health departments, emergency management organizations, and health care entities, to effectively prepare for and respond to public health emergencies and disasters.
More funding opportunities and challenge information (bottom of page)
In case you missed it:
  • FDA’s Commissioner’s Fellowship Program is accepting applications for the Class of 2016 from April 1 - May 12, 2016. FDA invites outstanding health care professionals, scientists, and engineers to apply to its two-year 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.
  • FDA is seeking comments related to a proposed Nonclinical Study Data Reviewer's Guide template. Comment by May 3, 2016.
  • FDA posted five new medical device education modules to the CDRH Learn Program website covering Unique Device Identification (UDI). (March 29, 2016)

No hay comentarios:

Publicar un comentario