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Feature|Videos|May 21, 2026

The Evolving Relationship Between FDA and Biotech

David Crean, chief business officer at MedicNova, highlights bifurcation in regulatory processes at FDA.

Marty Makary is the latest key leader at HHS to leave their role over the past two years. Aside from the coming and going of important roles, the current administration also has plans to majorly overhaul FDA and the drug approval process.

As a result, the industry is struggling to keep up with the changes. Under Makary’s leadership, a number of surprising CRLs were issued. While biotech companies attempt to adjust their strategies, investors are also changing their view of the industry.

David Crean, chief business officer at MedicNova, recently spoke with Pharmaceutical Executive about the industry’s attempts to improve communication and coordination with FDA. He also addressed the issues investors are paying attention to, which are primarily related to seeking greater regulatory certainty.

Pharmaceutical Executive: How will the relationship between biotech and FDA evolve in the coming months?
David Crean: You're still going to see some continued bifurcation. We had PDUFA back in the 90s. Now we have a lot of other things that have been layered on top of that.

You have the national priority review shrinking that that period of time from about 10-to-12 months to just one to two. You have the discussion about having one phase three as a default. There are other mechanisms or pathways to accelerate assets that the FDA generally wants to accelerate.

Those are all very good. I certainly think the execution part still needs to be looked at to make sure that investors and companies understand which lane is going on.

Secondly, with so much going on with AI, it's a little bit of bifurcation. You have AI being done at FDA, with Elsa looking at things, but they're a little bit behind in terms of how they're giving guidance to industry.

There's this gap in the marketplace. There’s a lot of things going on internally with AI at FDA, but externally, we're a little bit behind in terms of getting guidance from FDA and how they're going to shape the next decade of regulatory architecture in that area.

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