U.S. Food and Drug Administration
An IND Approved for Zika Virus
The US FDA recently approved an investigational new drug application (IND)* for a test to screen blood donations for Zika virus. The test is manufactured by Roche Molecular Systems, Inc. (Roche).
*: The IND regulations 21 CFR Part 312 (downloadable in PDF here) provides procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND’s). It applies to all
clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA) or to the licensing provisions of the Public Health Service Act (PHSA).
The screen test may be used for screening donated blood in areas with active mosquito-borne transmission of Zika virus according to the FDA announcement, dated March 30, 2016.
“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those U.S. territories already experiencing active transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”
Centers for Disease Control and Prevention (CDC)
The CDC presents the following educational video entitled “Zika Virus 101“
[youtube_advanced url=”https://www.youtube.com/watch?v=A1_SiG0yEUw” controls=”no” loop=”yes” rel=”no” modestbranding=”yes”]
The FDA further states:
“The close collaboration between the FDA and the product manufacturer was essential to expediting availability of this investigational test,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “This type of cooperation, which is typical of the FDA and its U.S. government partners during all public health emergencies, requires a tremendous agency effort and underscores the importance of having adequate resources available to support essential Zika virus response activities.”
On Feb. 16, the FDA issued guidance entitled “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion Transmission of Zika Virus” to blood establishments to reduce the risk of transfusion-transmitted Zika virus.
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Last Updated: 2016-04-05
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