Are Your Test Methods Scientifically Valid: Follow-Up

As a follow up to my previous post, I created a new chart that allows me to monitor trends in particular regulations. The above chart (high resolution pdf) shows how the number of citations for 21 CFR 111.75(h)(2) have changed over time.  Obviously there is a growing focus on scientifically valid methods, even though the overall number of citations is low.  We’ll see if this trend continues in FY2023.