Amid Coronavirus Outbreak, FDA and Industry Seek Roadmap for Emergency Diagnostics
Just as some manufacturers hasten to make tests available for the novel Wuhan coronavirus, FDA will convene with industry representatives Monday in hopes of developing a better “roadmap” for how diagnostics are evaluated during and potentially after emergencies.
The workshop was planned months before the Chinese outbreak to address the relatively few diagnostics that make the transition from emergency use authorization to full marketing status.
“Often what happens is that you get those diagnostic tests out in the market, use them during an emergency, and then when the emergency is waning, they are not submitted for approval to FDA,” said Danelle Miller, Roche Diagnostics’ vice president of global regulatory policy and intelligence.
Regulators and manufacturers alike have recent lessons to draw from, given that HHS issued declarations authorizing emergency use of diagnostics for Ebola virus in 2014 and Zika virus in 2016. HHS issued a declaration for the coronavirus Friday, following the World Health Organization officially labeling the outbreak a public health emergency, the sixth such declaration since the designation was created in 2005.
While EUA serves a clear purpose in emergency cases with no available diagnostic alternatives, a transition to full marketing status reflects additional data to back safety and effectiveness, giving healthcare providers further assurance, FDA said.
Once an emergency is contained, the “population-based medical value assessment and the business case for commercializing a test may vanish as the epidemic resolves and as test use diminishes.”
Written by: Maria Rachal
Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.
Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.