FDA Updates Recommendations to Prevent Spread of Zika Through Blood Transmission in US

August 31, 2016

FDA Revises Guidance Regarding Zika Transmission

On February 16, 2016, FDA published a guidance document that provided blood establishments with recommendations to reduce the risk of contaminating the US blood supply with the Zika virus.  On Friday, August 26th the FDA revised this guidance, stating that all blood and blood components that are donated in the US should be tested for the Zika virus.

When the FDA issued its original guidance, its contents only applied to areas with active Zika transmission.  As such, all areas in the US with active transmission are currently in compliance with this guidance.  However, as a further safety measure against the Zika outbreak, the Agency is now recommending “that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.”

FDA notes that it published this update after carefully considering all available scientific evidence, consulting with other public health agencies, and considering the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy.  All blood donated in in Florida, Puerto Rico, and other areas is already undergoing such testing.  This testing has proven to be helpful in identifying donations infected with the Zika virus.  FDA feels that “expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.”

For additional information on FDA’s recommendations, view the Agency’s full guidance document as well as the related news release.

Regulatory Sciences Prescription pills and packets on a table.

October 12, 2022

Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...

Read the Full Article
Agency Alerts General Regulatory

May 19, 2016

Compassionate Use for Investigational Drugs: FDA to Improve Awareness & Transparency of Expanded Access Programs

The Reagan-Udall Foundation for the FDA (RUF), a non-profit organization created to help the FDA accomplish its mission, is in the process of developing an online Navigator to help patients and...

Read the Full Article
Agency Alerts General Regulatory

August 1, 2016

FDA Issues Recommendations for the Form and Content of a Unique Device Identifier

On September 24, 2013, the FDA published the UDI Rule, which established a standardized identification system for medical devices used in the United States. Under this rule, the label and packages of...

Read the Full Article