Navigating FDA’s Regulatory Framework

In the realm of new drugs, biologics, and medical devices, the fundamental resources of time, money, and energy are scarce; therefore, knowing how to get new products to market is critical.

Everyone in the field knows that the line between conception, lab bench, and commercial use is long and far from straight. Everyone also knows this line passes directly through the Food and Drug Administration.

When the line reaches the FDA, it can become circuitous, come to a dead stop, or can continue uninterrupted. “Uninterrupted” is obviously the best outcome, but the attainment of “uninterrupted” takes forethought and strategic planning — it does not happen by accident.

That is why the CRI invited Jeremiah Kelly, Esq., a proven expert in FDA mechanisms, to conduct a two day seminar entitled “Navigating FDA’s Regulatory Framework for Medical Products.” Over the course of October 22 – 23, Mr. Kelly charismatically provided industry professionals, faculty, and students a contoured map of the regulatory landscape.

On day one of the seminar, Mr. Kelly disclosed the logic undergirding the FDA’s regulatory system. He described each product category (e.g., drugs, biologics, devices), and elucidated the variegated application pathways and evaluative measures for each. He detailed the incentives of marketing exclusivity and the transferability and resultant high value of Priority Review Vouchers.

On day two, Mr. Kelly tackled the complexity and rising appearance of combination products. He outlined special designations and approval pathways (e.g., Fast Tracking, Breakthrough Therapies), current product trends (e.g., stem cell therapies, medical mobile apps, biosimilars), and product advertising and labeling principles. The seminar concluded with the importance of aligning manufacturing processes with FDA guidelines and how the enforcement arm of the FDA functions and prioritizes investigatory and legal action.

Mr. Kelly’s clarion call to be aware of and understand FDA categories and incentives was heard, and all present perceived the obvious value of his roadmap. Comprehending the logic and incentives of the FDA influences research and development from the outset, and utilizing accelerated approval pathways (which must be completed at the first stage of the approval process) leverages scarce resources.

As Northeastern attendees assimilate this information, there is no doubt that NU research programs and entrepreneurial endeavors will have an edge when engaging the FDA and moving products to market.

There is also no question that the CRI will tap into Mr. Kelly’s knowledge again as his expertise helps make crooked lines straight.

To view Mr. Kelly’s full presentation materials, please click here.

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