Navigating FDA

The basics of drug development are well known in many labs – but what happens when you have to shift from that general understanding to developing specific plans for your own project?  What’s most important to think about? Where do you find information? When do you engage with FDA or a regulatory professional?  During this talk you will learn how to find information to inform your specific development effort, and how to recognize when its time to call in the professionals. 

Many types of medical devices, diagnostics, and digital health products must be reviewed by the FDA Center for Devices & Radiological Health (CDRH) before they hit the market. It can be daunting for innovators to determine which regulatory approach is applicable to their technology, and how to plan ahead for their interactions with FDA. In this webinar, an overview of the most common pre-market pathways will be provided, along with several key concepts. Attendees will gain a better understanding of where to start and where to find CDRH regulatory resources relevant for their own commercialization strategy.

Presenters:

Chris Sasiela, PhD, RAC has over a decade of experience providing regulatory support and consultation to academic innovators and small businesses engaged in therapeutic, device, and diagnostic development programs. As the Innovator Support Team Lead in the SEED (Small Business Education and Entrepreneurial Development) office at the National Institutes of Health, she coordinates the activities of a team of seasoned professionals with experience in product and business strategy, business development, fundraising, partnerships, reimbursement, and regulatory affairs. Chris is passionate about enabling NIH’s innovator community to progress their discoveries as far as science and human biology permit. Dr. Sasiela earned a bachelor’s degree in Chemistry from Whittier College, a Ph.D. in Pharmaceutical Sciences from the University of Maryland, School of Pharmacy, and has maintained Regulatory Affairs Certification status from the Regulatory Affairs Professional Society since 2011.

Ben Berman, PhD, is a member of the Innovator Support Team in the NIH Small Business Education and Entrepreneurial Development (SEED) Office. SEED supports the NIH innovator community in their efforts to validate the potential health impacts of promising scientific discoveries and advance them into healthcare products that improve patient care and enhance health. Prior to supporting NIH, Ben worked at FDA in the Center for Devices and Radiological Health – both as a lead reviewer in the Division of Radiological Health, and as a research fellow in the Division of Imaging Diagnostics & Software Reliability. Ben is a contractor and part of the MITRE Corporation’s Emerging Technology Innovation Center.