FDA Seeks Input On Emerging Sciences And Technologies

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) is asking scientists and technology experts from the private sector to provide the agency with valuable input on emerging issues and cross-cutting scientific advances that could impact regulation within five to 10 years.

Since its formation in April 2015, FDA's Emerging Sciences Working Group has been engaged in so-called "horizon scanning" meetings and assessments with industry representatives and FDA product research centers to gather information on emerging trends, with the aim of helping the agency better cope with future challenges.

The group recognizes that, to cast a wider net, it needs input from the private sector in order to better predict and prepare for scientific advances on the horizon, and it has opened a public idea portal for the purpose.

Electronic submissions to the Emerging Sciences Idea Portal will be public. Those wishing to submit comments with confidential information should do so in writing, according to the agency.

While FDA is keen on exploring the next scientific breakthroughs, FDA says it’s not interested in advanced areas of research that already are being developed or applied into actual products. Rather, they want to hear about scientific ideas, trends, and very early-stage technologies that are currently unknown to most scientists, but could impact FDA's mission in the near term.

"We are not focused on evolving areas such as nanotoxicology, since nanoparticles are already in some approved products even though the field is still being developed and understood. Our goal is to identify areas not yet addressed in current products like hibernation for surgery and brain-computer interfaces," Donna L. Mendrick, Ph.D., FDA’s Associate Director for Regulatory Activities at the National Center for Toxicological Research, wrote in a blog post.

"We’re not looking for advances that are already under discussion. We’re seeking information about scientific and technological advances that are so unknown they don’t show up – or barely show up – on a web search," she wrote.

"Emerging sciences, such as synthetic biology, are expected to impact FDA regulated products in the relatively near term. The goal of this initiative is to identify issues and advances that will impact the Agency in the longer term and thus may be in their infancy," added the FDA in a notice published in the Federal Register.

FDA said it will use the information gathered from the portal – along with ongoing feedback from FDA's leaders, other government agencies, and other stakeholders engaged in research – for science-based planning, programs, policies, reporting, and communication within and outside the agency.