The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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Elsa, HALO, and AICA: Comparing the FDA's AI Tools With Ours
The FDA's tools and those industry teams are buying solve different problems. Here's a quick look at where they actually meet, and where the comparison…
 • The FDA Group
7 Audit Program Planning Moves to Make in Q3
A quick checklist for Quality teams putting their 2027 audit schedule together.
 • The FDA Group
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
FDA Warning Letter Breakdown: The Early QMSR Letters Keep Landing on Risk Management
Three letters, three Clause 7.1 citations, and three different ways to fail it. Here's what FDA actually cited, and what to check in your own system…
 • The FDA Group
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
Guidance Breakdown: FDA Finalizes Its Meeting Framework for OTC Monograph Drugs
A breakdown of CDER's July final guidance on formal meetings under section 505G. The disclosure rules are the part to read twice!
 • The FDA Group
RA/QA News Roll: Mid August 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
 • The FDA Group
Planning Your 2027 Audit Program: What to Have Ready and When (Plus a Free Workbook!)
Our guide to annual audit planning, an open invitation to get your program resourced now, and an Excel workbook you can use to put your plan together.
 • The FDA Group
Trump Nominates Heidi Overton for FDA Commissioner
What we know so far, and what it may signal about the agency's direction.
 • The FDA Group
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
Managing AI Risk Across Global Quality Systems
How do you manage AI risk across global quality systems while the tools change every week?
 • The FDA Group
32:07
Ask Us Anything About AICA
We're recording an in-depth AICA session soon. Submit a question and we'll take it on during the demo!
 • The FDA Group
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