Continuing to strengthen FDA's science approach to emerging technologies Rachael Anatol, PhD, Steven Bauer, PhD, Suzanne Epstein, PhD, Ross Filice, MD, Kristina Lauritsen, PhD, Mark H. Lee, PhD, Elizabeth Mansfield, PhD, Michelle McMurry-Heath, PhD, Joseph Milone, PhD, Carlos Peña, PhD ⁎ , Steven Pollack, PhD, Issam Zineh, PharmD, MPH, FCCP Emerging Technology Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD, USA Received 1 March 2013; accepted 11 April 2013 Abstract Emerging technologies result when advances and innovation in technology lead to discoveries. Often emerging technologies stimulate novel research in medical product development that contribute to new approaches to manufacturing and can improve the quality of products. By supporting investments in agency coordination, staff training and professional development, regulatory science research, stakeholder engagement, and enhancing opportunities for expert input, the U.S. Food and Drug Administration plays a critical role in translating innovations into novel safe and effective medical products that improve the public health. © 2013 Published by Elsevier Inc. Key words: FDA; Science; Emerging technologies Emerging technologies result when advances and innovation in technology lead to discoveries. Often emerging technologies stimulate novel research in medical product development that contribute to new approaches to manufacturing and can improve the quality of products for consumers. 1,2 The U.S. Food and Drug Administration's (FDA) mission is to protect the public health by assuring the safety, effectiveness, quality, and availability of a wide range of products 3 including medical products that can incorporate emerging technologies. FDA regularly evaluates the combination of promise, risk, and uncertainty inherent in new products and technologies. 4 In doing so, the Agency continues to take steps to foster responsible development of innovative medical products and provide regulatory clarity to industry, which is critical to FDA's mission. 5 FDA's ability to support the responsible development of emerging technology products requires application of relevant laws, regulations, and guidance. Equally critical is the knowledge and understanding of science, active engagement of FDA's expert scientific staff, and building a strong infrastructure (collectively referred to as FDA's science capacity) to guide science-based and science-led decision making. A strong science capacity not only ensures the Agency's ability to review products incorporating the latest technology, but also prepares the Agency for future submissions. In this article, we discuss emerging technologies and a few of the Agency activities that help facilitate the development of products derived from emerging technologies including: 1) establishing lines of communication; 2) coordinating and making transparent agency activities; 3) creating opportunities for staff training and professional development; 4) supporting intramural and collaborative regulatory science research; and 5) engaging external stakeholders through workshops, advisory committees, and other mechanisms. What are some emerging technologies? Emerging technologies represent groundbreaking advances and innovation in technology, may provide tools to solve Nanomedicine: Nanotechnology, Biology, and Medicine xx (2013) xxx – xxx nanomedjournal.com ⁎ Corresponding author. E-mail address: carlos.pena@fda.hhs.gov (C. Peña). 1549-9634/$ – see front matter © 2013 Published by Elsevier Inc. http://dx.doi.org/10.1016/j.nano.2013.04.005 Please cite this article as: Anatol R., et al., Continuing to strengthen FDA's science approach to emerging technologies. Nanomedicine: NBM 2013;xx:1-6, http://dx.doi.org/10.1016/j.nano.2013.04.005