Early Interactions With FDA and Developing the Value Story for Your Innovative Product

David Fox, Randy Prebula, Beth Roberts, and Susan Lee will be speakers at the Harvard Innovation Labs. They will have an interactive discussion that will cover:

– 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;

– Understanding the reimbursement landscape for your product early on, and generating data through the development process that will support your product's value proposition.

Find Out More: Early Interactions With FDA and Developing the Value Story for Your Innovative Product


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