The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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What Auditors Are Actually Looking For — And the Psychology Behind How They Find It
A lead auditor's perspective on why logistics matter more than most companies think, how to handle the silence trick, and what it takes to make audit…
 • The FDA Group
19:30
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That with John Butler
Akebia's CEO on the regulatory clarity fueling rare kidney disease investment, the reimbursement structure starving dialysis of innovation, and the…
 • The FDA Group
35:12
Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
What it takes to align three major regulators on a single development program, and why treating ICH compliance as hard regulatory alignment is a…
 • The FDA Group
28:53
Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
What changes (and what doesn't) when regulatory leaders move between structured enterprises and resource-constrained startups.
 • The FDA Group
32:46
Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
How life science companies can better govern their data to meet structured submission requirements, minimize regulator questions, and unlock the real…
 • The FDA Group
28:05
Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
A few lessons on adaptability, intentional innovation, and empowering teams to navigate scientific uncertainty.
 • The FDA Group
37:59
Consultant Spotlight: What 30+ Years of FDA, Consent Decree, and GMP Work Teaches You About Fixing Real Quality Problems
A conversation with one of our senior consultants, Neal Siegel, PhD, on system-level thinking, consent decree lessons, and what experienced quality…
 • The FDA Group
29:09
Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
How disciplined knowledge transfer, risk management, and communication prevent costly delays as products scale.
 • The FDA Group
35:24
Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
ISPE’s Mike Martin shares how automation, culture, and lifelong learning are redefining what it means to work in pharma.
 • The FDA Group
42:34
How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
Tolmar’s Senior Vice President of Quality and Chief Quality Officer shares how teams can embed quality as a lived value—from the executive suite to the…
 • The FDA Group
43:27
From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
A veteran regulatory strategist, global submission leader, and commercialization advisor walks us through how to navigate the clinic-to-commercial…
 • The FDA Group
48:45
How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
DIA’s Chief Science & Regulatory Officer explains how FDA and global counterparts are adopting AI for efficiency while preserving scientific rigor…
 • The FDA Group
51:29
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