Hosted by Dr. Eugene Krentsel, Chief Scientific Officer of XLerateHealth, this webinar will be split into two sections:
1. Drug (and Biologic) Development Requirements – Dr. Sasiela, NIH
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.
2. Device (and Diagnostic) Development Requirements – Dr. Berman, MITRE
During this talk you will learn how to find information to inform your specific development effort, and how to recognize when it’s 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.