Sophisticated new technologies don’t always fit neatly into the categories that the U.S. Food and Drug Administration (FDA) uses to classify and regulate medical products, such as “drug,” “biologic,” “medical device”, or “cell or tissue product”. And some novel technologies combine elements across more than one of these categories. Each of these product categories has a distinct regulatory pathway that can substantially shape the requirements and processes you will be subject to for development, approval, marketing, and post-approval obligations. Your product classification can also have a significant impact on how your product will be reimbursed, and having an early grasp of how your product can ultimately be paid for is critical to articulating your value story and attracting additional investment to build a viable company.
Thus, proactively understanding the implications of your regulatory pathway, identifying opportunities to engage early and productively with FDA, and developing your product with your reimbursement model in mind can directly influence your development costs, speed to market, and commercial potential. In other words, these are critical drivers for getting your innovative technology to market successfully and efficiently.
David Fox, Randy Prebula, Beth Roberts, and Susan Lee of Hogan Lovells will lead an interactive discussion that includes:
• An overview of the various regulatory pathways under FDA’s regulatory framework, highlighting considerations that are particularly relevant to innovative products;
• Principles for interacting with FDA’s review divisions early and effectively (e.g., pre-IND and pre-IDE meetings) to smooth your path to market; and
• Understanding the reimbursement landscape for your product early on, and generating data through the development process that will support your product’s value proposition.