Medical technology innovation is exploding and disrupting longstanding patterns of innovation, research, development, regulation, and marketing in the life sciences industry. Big data, the Internet of Things, neurotechnology, AI, and cloud computing are just a few recent innovative tools. The pace of change is unrelenting, but is FDA able to regulate these emerging technologies without compromising innovation or delaying the next generation of technology to patients in need? What programs and policies have FDA considered, and must Congress provide new authorities to FDA to address the challenges in line with FDA’s core public health mission?
Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP
Ellen Flannery, Deputy Center Director for Policy, CDRH, FDA
Grail Sipes, Deputy Center Director, Regulatory Policy, CDER, FDA
Andrew Wasson, Partner, Haug Partners LLP
Moderated by Elizabeth R. Jungman, Director, Public Health Programs, The Pew Charitable Trusts and Member, FDLI Board of Directors