The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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Pharma Tech Transfer Is Knowledge Transfer, with Paige Kane, PhD, CPIP
CAI’s Paige Kane on why the “know-why” rarely makes it into the documents, and the structured questions that bring it to the surface.
 • The FDA Group
17:58
The Adoption Assumptions Hiding in Your Regulatory Strategy, with Holley Miller
A 30-year medtech marketer on the adoption assumptions hiding inside every regulatory pathway decision, and why “better” so rarely wins.
 • The FDA Group
1:03:37
Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success
The two-time FDA Commissioner on treating a patient versus improving a population's health, why access to these drugs has followed resources, and why he…
 • The FDA Group
33:22
Is Your Biotech De-Risking or Just Delaying?
Baseimmune's CEO Kevin Walton on beachhead decisions, why accumulating supportive data can be a form of procrastination, and what’s actually getting…
 • The FDA Group
34:57
Reg Ops Has Been Kept in a Box. This Is the Way Out, with Carla Griffin
Why FDA's real-time clinical trials work is an opportunity for regulatory operations professionals rather than a threat, and what to do in the next…
 • The FDA Group
24:00
QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
Why late QA involvement doesn't just cost money, it removes your cheap options. And what phase-appropriate quality actually looks like now from…
 • The FDA Group
28:11
What Shaped You Isn't on Your Resume, with Jessica Smith, PhD
A medtech executive on resilience built long before any title, why owning a loss is what makes it fixable, and the difference between bouncing back and…
 • The FDA Group
1:00:05
Nice Is Not Always Kind: Emotional Safety in Small Companies with Nichole DiLoretta
Why the quiet employee is your earliest warning sign, what the "company psychologist" is absorbing that nobody assigned them, and the one place leaders…
 • The FDA Group
53:17
Managing AI Risk Across Global Quality Systems with Julio Salwen
MiniMed's Chief Quality Officer on why compliance should be a byproduct, not the goal, what "know enough to be dangerous" actually means, and why you…
 • The FDA Group
32:07
The Case for Engaging Regulatory Early with Leland Keyt
Most companies bring regulatory in when they're ready to submit. A 20-year MedTech regulatory leader on why that's already too late, and what it costs.
 • The FDA Group
22:15
Why Quality and R&D Default to Conflict (and How to Fix It)
A former VP of Quality on the learned behavior behind the roadblock stereotype, why Quality usually gets the last timeline, and what it takes to be a…
 • The FDA Group
30:29
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
The head of the American Society for Quality on why AI is now a leadership problem, not a technology one, and what executives owe their people through…
 • The FDA Group
49:13
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