![]()
Again showcasing our Regulatory Reconnaissance series, Chief Editor Tom von Gunden’s commentary below references a related guest column in which regulatory expert Doug Mead reports on research into FDA precedents around Human Factors.
Start your Human Factors exploration here!
Regulatory Attention To Human Factors: How Much Is There?
By Tom von Gunden, Chief Editor, Drug Delivery Leader
I’m back on the beat of precedent research conducted to bolster regulatory intelligence. I recently commented on the practice as a submission-support strategy in my editor’s take, “Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions.” In providing a high-level framing of the rationale behind the approach, I consulted for that piece combination products regulatory expert Doug Mead, a leading proponent and practitioner of employing GenAI tools for precedent research.
That article’s embedded Q&A with Doug had me asking him about his fuller explanation of precedent research in a guest piece he had authored for Drug Delivery Leader, “GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products.” Together, my editorial overview and Doug’s detailed guest column were intended to serve as foundations for subsequent sets of companion pieces demonstrating the concept of precedent research translated into practical application.
For the first of those theory-into-practice illuminations, we chose Human Factors. Along with this From The Editor article you are currently consuming, the tandem includes Doug’s just published guest column, “Human Factors: A Key Factor In Regulatory Approvals.” In the video and transcript below, you’ll find me talking with Doug about his article and the insights he offered in it after querying FDA databases on HF-related regulatory precedents.
Heightened Human Factors Scrutiny Should Not Surprise
Why Human Factors as our first-up demonstration of a precedent research strategy? Well, we’ll get Doug’s thoughts on that in the video and transcript below. From my editorial angle of vision on the drug delivery regulatory landscape, I see several reasons why biopharmaceutical product development organizations may face increasing regulatory scrutiny around HF-related considerations. These would include device design, usability, user error, dosing accuracy, patient safety, and any other potential causes of or, ideally, protections from risk and harm.
Continue Reading…
Again showcasing our Regulatory Reconnaissance series, Chief Editor Tom von Gunden’s commentary below references a related guest column in which regulatory expert Doug Mead reports on research into FDA precedents around Human Factors.