Originally published May 2025.
Welcome to Insider issue #37.
Also, hello to the 325 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
This issue marks a defining moment for artificial intelligence in regulated industries. FDA has issued not one but two major draft guidance documents on AI—one for drugs and biologics, another for medical devices—and the message couldn’t be clearer: the era of “black box” AI in regulatory submissions is over. Companies that can’t explain how their models work, what happens when they fail, and how they’re monitored over time will face delays, rejections, and competitive disadvantage.
In our first analysis, Leonid Chagal dissects the FDA’s new 7-step credibility framework for AI used in drug and biologic regulatory decision-making. His breakdown covers credibility plan requirements, lifecycle management expectations, and actionable steps for building the governance infrastructure FDA now demands.
Judson Russell follows with an examination of the FDA’s companion guidance for AI-enabled medical devices, focusing on the Risk Management File approach, postmarket performance monitoring, and what developers need to know to submit successful applications.
Finally, Jonathan Wacks returns with his signature warning letter analysis, examining three recent enforcement actions against offshore OTC and API manufacturers in China and India. His insights reveal the FDA’s continued focus on ingredient quality, DEG contamination testing, and the severe consequences facing firms that violate data integrity standards.
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