In July of this year, Krieger Scientific issued a release addressing the increase in 303 drug warning letters issued by FDA. In his original statement, he said, “The FDA recommended outside compliance expertise in 87 percent of the warning letters it reviewed last year. Morwald spoke with Pharmaceutical Executive about the increase in warning letters and what he sees as the exact issues causing it. Pharmaceutical Executive: What is the significance of FDA sending its first warning letter about inappropriate use of AI? This problem exists beyond life sciences, but in life sciences it carries a different weight entirely.