BARDA obtains 85th FDA regulatory approval for supported products

It has been a busy year for the Biomedical Advanced Research and Development Authority (BARDA), which announced this week its 85th Food and Drug Administration (FDA) regulatory approval for supported products – and brought its total approvals and clearances for the year to 20.

“BARDA has been at the cutting edge of public health research and development since their inception,” Assistant Secretary for Preparedness and Response Dawn O’Connell said. “The innovative products we have supported are powering our response to COVID-19, mpox, and countless other public health challenges – strengthening our response capabilities and building our preparedness for future threats.”

BARDA has come a long way since its first support product achieved FDA approval in 2007. Back then, it was a Sanofi Pasteur vaccine that became the first licensed vaccine for the H5N1 influenza virus. Since then, BARDA has helped 38 diagnostics and devices achieve clearance, along with 23 indications for treatments and another 23 licensed indications for vaccines. The agency helps public health preparedness by aiding companies through the phases of development and the regulatory oversight process.

In the case of its 85th clearance, the product aided was the QScout system, a new point-of-care hematology device from Ad Astra Diagnostics that uses image-bases analysis on drops of blood to classify white blood cells in patient samples with a quick turnaround.

“Since 2006, BARDA has supported the development of lifesaving medical countermeasures to protect Americans from public health emergencies,” BARDA Director Gary Disbrow said. “The 85th approval highlights our efforts to prepare against new and emerging threats, catalyze innovation in advanced research and development, and focus on strengthening the health security of our nation.”

In a statement, BARDA also pointed to other products that have benefited from its help, including more than 1 million vaccines and treatments developed and stockpiled for a smallpox emergency during the mpox outbreak of 2022 and a slew of diagnostics, vaccines, and treatments deployed during the COVID-19 pandemic.