Navigating the FDA Emergency Use Filing Process

In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one nonprofit set out to fill this critical gap for hospitals across the U.S. However, they needed guidance as they moved through the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) filing process. The EUA authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Having never done this before, the nonprofit turned to Advarra’s global experts to guide them through this process. Together, both organizations collaborated through strategy to execution to successfully obtain an EUA from the FDA.

Process

As this nonprofit and Advarra began to work together, Advarra leveraged key members of its Regulatory and Quality Centers of Excellence (CoEs) to deliver strategic and tactical support across a wide range of skills. Team members included:

• Regulatory experts to lead the FDA Authorization communication and filing process
• Quality experts to help qualify and certify the nonprofit’s manufacturing facility
• A packaging expert to help design and develop the device packaging

As a team, Advarra’s global experts worked together to help frame the nonprofit and their business model for advancing their medical device to various federal and state agencies. Advarra’s global reach connected the nonprofit to potential manufacturing partners and philanthropies. Through these connections, this nonprofit accelerated product development for production capacity up to 1,000 units per week.

Providing FDA Communication Expertise

To get this nonprofit ready for EUA submission, Advarra’s Regulatory CoE team prepared team members for the pre-investigational new drug (IND) meeting. Prior to this meeting with the FDA, Advarra regulatory experts also assisted the nonprofit as they submitted a letter to the FDA requesting this meeting. This letter included itemized questions designed for the FDA to review and discuss. After these questions were received, the FDA set up a meeting with the nonprofit 60 days after the initial request.

Thirty days prior to the meeting, the nonprofit submitted a briefing document with the same questions initially posed, but with scientific detail. The FDA met prior to the pre-IND meeting, and this became the basis for the meeting itself.

Additionally, Advarra’s regulatory experts provided guidance for the nonprofit to navigate the pre-new drug application (NDA) meeting. Scheduled four to six months ahead of a formal submission, this meeting discusses topics such as (but not limited to):

• Program results
• Location of results within the NDA
• Addressing issues raised in the development program
• Follow up on issues raised during the end of the Phase II meeting

Results

Within three weeks, the nonprofit had working units of its medical device in testing at a local hospital, and within five weeks, the FDA granted EUA to them.

Since receiving their EUA, the first batch of units were manufactured with a validated design. The nonprofit also scaled up to provide ventilators for rural and global needs with a production capacity of 1,000 units each week. This helped fill critical gaps in areas with the biggest shortages when organizations needed it most. Access the Case Study

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