In 1951, the United States Air Force had a question that could not be answered by experiment: how many atomic bombs would be required to significantly disrupt U.S. industrial capacity under nuclear attack? There were no historical precedents to draw on, no experiments to run, no datasets to analyse. All the Air Force had …
In 1990, while serving as director of the internal medicine residency program at McMaster University in Hamilton, Ontario, Gordon Guyatt introduced a new approach to teaching at the bedside. He called it “Scientific Medicine.” The idea was straightforward: clinical decisions should be grounded in a critical appraisal of the best available evidence, not in …
This is the first in a five-part series on the science and methodology behind clinical practice guidelines and consensus statements. The series “From Hippocrates to Delphi” is named for the arc that connects the earliest attempts to codify medical practice to the structured consensus methods we use today. Hippocrates gave us the idea that clinical …
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”
On March 25, 2026, I attended MAX: Medical Affairs eXcellence Forum, Canada’s first forum dedicated entirely to medical affairs in biopharma. Organized by Agilis Health and held at the Sheraton Toronto Airport, it brought together 140+ professionals spanning Medical Affairs, Pharma, Clinical Research, Regulatory, and Medical Communications for a full day of candid, high-calibre conversation. …