IT and the new FDA
Historically, FDA interactions were led by Regulatory Affairs, Clinical, Quality, and the business. IT was often brought in later to implement the solution or take part in an audit.That model is quickly becoming outdated.
One of the biggest shifts happening in biotech and pharma isn’t just AI—it’s who needs to be in the room.
Historically, FDA interactions were led by Regulatory Affairs, Clinical, Quality, and the business. IT was often brought in later to implement the solution or take part in an audit.
That model is quickly becoming outdated.
Today’s regulatory discussions increasingly involve AI, cloud platforms, cybersecurity, data integrity, digital biomarkers, real-world evidence, connected devices, and advanced analytics. These aren’t simply technology projects—they’re core components of the products, processes, and evidence being presented to regulators.
If IT isn’t part of the conversation from the beginning, organizations risk designing solutions that are difficult to scale, expensive to retrofit, or challenging to validate.
The most forward-thinking life sciences companies are treating IT as a strategic partner—not an order taker. Bringing technology leaders into FDA discussions early leads to better architecture, stronger compliance, faster execution, and ultimately better outcomes for patients.
In the AI era, technology strategy and regulatory strategy are becoming inseparable.
I think this is an especially important message right now because many organizations are still operating under the old model, while the FDA is increasingly evaluating software, AI, data governance, and digital evidence as integral parts of therapies and medical products—not just the infrastructure supporting them.
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