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. …
In the first three articles of this series, we looked at AI where people can see it: reading scans and drafting treatment plans, tutoring students and simulating patients, and even helping design the next generation of medicines. But some of the most profound changes are happening out of sight, in the operating system of the …
One of the latest health crazes to slip in alongside “peptides” (see our previous series), is the idea that powerful medicines can be repurposed as lifestyle tweaks by “microdosing”: a tiny dose of a diabetes drug to “optimize” metabolism, a fraction of a psychedelic to sharpen focus, or a whisper of a stimulant to fuel …
Continue reading “Beyond the Hype: Why Microdosing Falls Short of Science”
The first article of this series argued that the peptide boom is not just a fringe fad but a parallel ecosystem, built by people who feel conventional medicine is too slow, too narrow, or too inaccessible for the goals they care about. In our second article, we asked how far bodily autonomy should extend when …
Continue reading “The Peptide Paradox (3): When the System Has No Middle Ground”