Health Law Advisor

Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than others. This month, continuing the analysis I started in my October post regarding device-related citizens petitions, I used topic modeling on the citizens petitions to see which topics are most frequent, and whether there are significant differences in the amount of time it takes for FDA to make a decision based on the topic.

Discerning the Topics

As you probably ...

This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions.  Make no mistake, I have an interest in this topic.  Over the more than 35 years I have been practicing law, I have filed multiple petitions including a 1995 petition that successfully caused FDA to adopt Good Guidance Practices.  But more recently, specifically on February 6, 2023, I filed a citizen petition asking FDA to rescind its final guidance on Clinical Decision Support Software.[1]  On August 5, 2023, when we ...