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”
Here’s a pattern I’ve seen repeatedly. A medical affairs team builds a publication plan. Timelines align to a congress deadline. Authors are confirmed. A solid first draft is delivered on time. Then the manuscript enters medical-legal-regulatory review, and disappears. Weeks later, it resurfaces covered in tracked changes that contradict each other. Medical pushes for bolder …
Continue reading “Your Publication Plan Isn’t Failing at MLR: It’s Failing at the Outline”
On March 30, 2026, I attended RISE Together: Data Sharing Across the Rare Disease Ecosystem [1] expecting a discussion about the platforms and infrastructure needed to move data more efficiently across systems. Instead, what surfaced over the course of the day was something more fundamental, and more difficult to resolve. The rare disease field is …
Continue reading “When the Data Exists but Doesn’t Travel: Lessons from RISE Together 2026”
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 our previous article, we reviewed the history of Patient Centered Care and how the Picker Principles provided a foundation for empowering patients and improving healthcare outcomes around the world. We highlighted that patient autonomy is a cornerstone of this approach, yet it is also one of the most challenging areas to effectively navigate. In …