A Higher Bar, A Wider Net: What ICH M14 and the New RWE Standards Mean for Medical Affairs In Part 1 of this series, we traced the arc from Frances Kelsey’s 1960 stand against anecdotal evidence to the emergence of real-world evidence as a formally recognized category of regulatory science. The story was one of …
Continue reading “RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 2.”
In the fall of 1960, a newly hired pharmacologist named Frances Kelsey received her first assignment at the FDA: review a drug called Kevadon [1]. It was, by all appearances, a routine case. The drug was already sold across Europe and Canada, prescribed to pregnant women to ease morning sickness. The manufacturer’s application was thick …
Continue reading “RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 1.”
Do you ever wonder why pharmaceutical ads on Canadian TV stations are so radically different from US ads? That’s because Canada has distinctly different regulations, stemming from Health Canada, regarding pharmaceutical advertising. In Canada, the Pharmaceutical Advertising Advisory Board (PAAB) is the independent, not-for-profit preclearance agency recognized by Health Canada to review and approve pharmaceutical …
Continue reading “What Canadians Don’t See: Inside the Rules Governing Pharmaceutical Advertising”
On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to a Michigan-based manufacturer of drug products called Purolea Cosmetics Lab. At first glance, it looked routine: cGMP violations, missing process validation, inadequate quality controls. But buried in the letter was something unprecedented: a dedicated section titled “Inappropriate Use of Artificial …
Continue reading “FDA Just Issued Its First AI Warning Letter: Medical Affairs Should Pay Attention”