The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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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
Growing Your Career in RA/QA with Jessica Beaver
A conversation about the questions every regulatory and quality professional eventually has to answer for themselves.
 • The FDA Group
53:41
Aurion Biotech's Chief Regulatory and Quality Officer on Leading When There's No Clear Right Answer
Sterling Chung on servant leadership, the trust formula, distilling emotion out of hard decisions, and why the last thing you do for someone is half of…
 • The FDA Group
51:01
NeuraSignal's VP of Quality on Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
Dan Eagles explains the back-engineered root cause, the "retrain the operator" trap, and how to rebuild CAPA into a tool people actually want to use.
 • The FDA Group
27:51
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