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

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

• Zika virus response updates from FDA
• Safety of the blood supply, with regard to Zika virus
• About regulation of the blood supply

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)

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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 Read the press release Related information Draft Guidance for Industry - Anthrax: Developing Antibacterial Drugs for Prophylaxis of Inhalational Anthrax (PDF - 565KB), new February 16, 2016 Animal Rule information

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Zika-related FDA guidance issued to date

• February 16, 2016: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF, 111 KB)

• March 1, 2016: Donor Screening Recommendations to Reduce Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (PDF, 78 KB)

• March 11, 2016: Questions and Answers Regarding - Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry (PDF, 310 KB) 

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News updates

Events:

• New! April 1, 2016: CDC is hosting a one-day Zika Action Plan Summit (Atlanta, GA) as the nation faces likely local mosquito-borne transmission of Zika virus in some places in the continental United States. Register to view the public webcast

• April 13-14, 2016: Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies(Bethesda, MD and webcast) - the purpose of this workshop is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies

• April 14-15, 2016: Public Workshop: Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification,  (Bethesda, MD) co-hosted by FDA and the National Institutes of Health Biomarkers Consortium - there is no fee to attend the workshop, but attendees must register by April 1, 2016 - register  by April 7, 2016

• April 19-22, 2016: Preparedness Summit  (Dallas, TX), hosted by the National Association of County and City Health Officials (NACCHO) (fee) - includes a Medical Countermeasures Link workshop  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.

• New! May 12, 2016: FDA Grand Rounds - Antibiotic resistance surveillance in the age of genomics: New answers to old questions, presented by Patrick F. McDermott, MS, PhD, FDA Center for Veterinary Medicine

View more events on the frequently updated MCMi News and Events page

Emergency Use Authorization (EUA) updates:

• FDA issued an EUA to authorize the emergency use of the CDC’s Trioplex rRT-PCR, a laboratory test designed to detect Zika virus and two other viruses (dengue and chikungunya) also spread by mosquito bites. Additional technical information - also see theFDA Zika response page and the CDC statement (March 17, 2016)

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 and NIH Release a Draft Clinical Trial Protocol Template for Public Comment - comment on the draft template by April 17, 2016 (March 18, 2016)

• 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)