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Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions
Mar 11
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The FDA Group
15
2
5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
Jun 26, 2025
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The FDA Group
16
1
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
Apr 14
•
The FDA Group
17
2
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
Sep 10, 2025
•
The FDA Group
10
1
What the First QMSR Inspections Reveal: Familiar Problems, a Sharper Lens
The FDA says it's now run more than 100 inspections under the new rule. The top findings are not a huge surprise. Where they're surfacing is the real…
13 hrs ago
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The FDA Group
7
1
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…
Jun 19
•
The FDA Group
3
1
51:01
RA/QA News Roll: Mid June 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 18
•
The FDA Group
4
1
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.
Jun 15
•
The FDA Group
4
1
27:51
One Way to Interrogate "Human Error" in CAPAs
An approach to a specific, recurring problem that has held up well in practice.
Jun 12
•
The FDA Group
13
2:59
Eric Boyd Introduces the Latest Version of AICA in 3 Minutes
A brand new demo of the Audit Intelligence Compliance Assistant.
Jun 12
•
The FDA Group
2
1
A Few Lessons From Our Recent Audits
Five deeper problems we found across this year's audit dataset.
Jun 11
•
The FDA Group
10
1
House Appropriators Tell FDA to Accelerate its IND Sign-Off
Congress wants faster entry into early-phase trials as drug development keeps shifting toward China and Australia.
Jun 11
•
The FDA Group
7
1
6 Ways to Stay Ready for FDA Inspections
Readiness depends less on last-minute preparation and more on whether your quality system is clear, defensible, and easy to execute every day.
Jun 10
•
The FDA Group
8
What AICA Actually Sees When It Looks at Your Procedures
A conversation with our contributor consultants on the one question AICA is built to answer, and the dimensions of compliance work it deliberately…
Jun 9
•
The FDA Group
3
1
Stop Asking Which AI Tool to Bet on in Quality and Regulatory
A primer on the argument around AI tooling we’re bringing to DIA 2026.
Jun 5
•
The FDA Group
4
RA/QA News Roll: Late May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 5
•
The FDA Group
4
Scoping the Real Risk of Data Integrity Issues in an Out-of-the-Box eQMS
When a clinical-stage biotech discovered its eQMS didn't have compliant audit trails and access controls, the urgent question was whether its document…
Jun 4
•
The FDA Group
3
1
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RA/QA News Rolls
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RA/QA News Roll: Mid June 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 18
•
The FDA Group
4
1
RA/QA News Roll: Late May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jun 5
•
The FDA Group
4
RA/QA News Roll: Mid May 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
May 19
•
The FDA Group
3
1
RA/QA News Roll: Late April 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
May 1
•
The FDA Group
3
FDA News
View all
House Appropriators Tell FDA to Accelerate its IND Sign-Off
Congress wants faster entry into early-phase trials as drug development keeps shifting toward China and Australia.
Jun 11
•
The FDA Group
7
1
A Quick Explainer on the FDA's Leadership Shakeups
There's been a lot happening. Here's a simple guide for catching up with recent personnel changes.
May 20
•
The FDA Group
5
1
The FDA's One-Day Inspection Pilot Is Already Running
What we know about the new "inspectional assessments."
May 7
•
The FDA Group
3
1
More OMQ Letters After FDA Inspections? Don't Treat Them as Noise
We're hearing that manufacturers are getting more post-inspection mail from CDER. Here's what the letters actually mean for your next inspection.
May 4
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The FDA Group
5
2
Podcast
View all
51:01
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…
Jun 19
•
The FDA Group
3
1
27:51
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.
Jun 15
•
The FDA Group
4
1
50:45
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
What PAIs actually check, why your investigations are probably written for the wrong audience, and why fear of an inspection usually points to a…
Jun 1
•
The FDA Group
8
2
30:38
TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Your quality system looks great on paper. Can your team actually defend it?
May 18
•
The FDA Group
5
1
Deep Dives
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1:14:09
[May 2026] FDA's NAMs Validation Framework, Finalized Patient Preference Information Guidance + Clinical Thermometer Warning Letter
Watch now (74 mins) | CDER tells you how to put new approach methodologies in front of reviewers, FDA finalizes guidance on patient preference…
May 27
•
The FDA Group
7
1
56:40
[April 2026] FDA Form 483 Response Guidance, Weight Loss Device Framework + AI-Driven Device Warning Letter
Watch now (57 mins) | The FDA finalizes how to respond when inspectors hand you a 483, publishes a premarket framework for weight loss devices, and…
Apr 16
•
The FDA Group
15
1
52:34
[March 2026] MoCRA Records Access for Cosmetics, Medical Device Cybersecurity + OTC Sterility Warning Letter
Watch now (53 mins) | FDA clarifies what investigators can demand from cosmetics under MoCRA, cybersecurity requirements align with QMSR, and a Texas…
Mar 9
•
The FDA Group
14
1
32:41
[February 2026] Bayesian Methods in Clinical Trials, Real-World Evidence for Devices + Warning Letter Analysis
Watch now (33 mins) | A Bayesian methodology draft guidance for clinical trial design, a finalized RWE framework for medical devices, and a Georgia…
Feb 5
•
The FDA Group
6
Audit Trend Reports
What Our Auditors Are Finding Lately: 8 Trends Across GMP, GLP, ISO, and CSV Audits (Q1 2026)
A look back at our recent audit reports, supplier qualifications, mock inspections, and internal assessments.
Apr 9
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The FDA Group
16
1
What Our Auditors Are Finding Lately: 10 Trends Across GMP, GCP, ISO, and GDP Audits (H2 2025)
A look back at our recent audit reports, mock inspections, gap assessments, and supplier qualifications.
Jan 23
•
The FDA Group
4
1
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
A look back at our recent audit reports and mock inspections.
Sep 10, 2025
•
The FDA Group
10
1
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