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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
15
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
16
2
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
Sep 10, 2025
•
The FDA Group
10
1
FDA Warning Letter Breakdown: A Manufacturer Tells Investigators Its AI Agent Never Said Process Validation Was Required
The firm outsourced both document production and decision-making to an AI tool.
8 hrs ago
•
The FDA Group
5
1
Guidance Breakdown: FDA Proposes Pulling Back on Premarket Requirements for NIOSH-Approved Respirators
A quick breakdown of the new draft guidance on compliance policy for certain NIOSH-approved air-purifying respirators used in healthcare settings.
10 hrs ago
•
The FDA Group
3
1
Preparing for Your Next Supplier Qualification Audit: A Field Guide
What to look for, what to push on, and where our common findings actually come from.
Apr 29
•
The FDA Group
13
1
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…
Apr 28
•
The FDA Group
9
1
19:30
10 Takeaways from FDA's QMSR Town Hall on Risk-Based Inspections
A quick breakdown of FDA's April town hall on risk-based medical device inspections under the new Compliance Program 7382.850.
Apr 28
•
The FDA Group
15
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
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
When a CAPA's effectiveness data shows the corrective action isn't working and the CAPA stays closed anyway, the quality system has a structural…
Apr 14
•
The FDA Group
16
2
35:12
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…
Apr 10
•
The FDA Group
8
1
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
•
The FDA Group
15
1
RA/QA News Roll: Late March 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Apr 3
•
The FDA Group
5
1
Embedding a Senior Consultant to Rebuild a Deviation Program at a High-Growth Biologics Site
How staff augmentation helped a biologics manufacturer move from reactive firefighting to structured deviation management.
Apr 3
•
The FDA Group
5
1
Why Embedding a Senior Quality Consultant Can Be the Fastest Way to Regain Control
When you have a backlog growing faster than your team can close it, the answer isn't always hiring. Sometimes it's deploying the right person to embed…
Mar 31
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The FDA Group
5
1
Guidance Breakdown: FDA Finalizes Updated Guidance on Patient Preference Information
The agency's new guidance expands the role of voluntary patient preference data across the entire device lifecycle. Here are the 12 key points we pulled…
Mar 31
•
The FDA Group
5
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RA/QA News Rolls
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RA/QA News Roll: Late March 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Apr 3
•
The FDA Group
5
1
RA/QA News Roll: Mid March 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Mar 24
•
The FDA Group
3
1
RA/QA News Roll: Late February 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Mar 10
•
The FDA Group
4
1
RA/QA News Roll: Mid February 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 16
•
The FDA Group
2
1
FDA News
View all
10 Takeaways from FDA's QMSR Town Hall on Risk-Based Inspections
A quick breakdown of FDA's April town hall on risk-based medical device inspections under the new Compliance Program 7382.850.
Apr 28
•
The FDA Group
15
1
An FDA Warning Letter Came With Pictures
A picture really is worth a thousand words (or in this case, a thousand lines of dense warning letter text).
Mar 24
•
The FDA Group
8
2
What’s Been Happening at the FDA Lately: A Roundup
The past several weeks have been among the most eventful (and chaotic) in recent FDA history. Here's what's been happening.
Mar 18
•
The FDA Group
3
1
A Quick Explainer on FDA's Consolidated Adverse Events Reporting System
The new Adverse Event Monitoring System (AEMS) consolidates decades of fragmented safety reporting. If your company submits adverse event reports to the…
Mar 17
•
The FDA Group
3
1
Podcast
View all
19:30
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…
Apr 28
•
The FDA Group
9
1
35:12
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…
Apr 10
•
The FDA Group
8
1
28:53
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…
Mar 30
•
The FDA Group
3
1
32:46
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.
Mar 19
•
The FDA Group
1
1
Deep Dives
View all
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
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The FDA Group
6
35:54
[January 2026] IND Safety Reporting Guidance, eCopy Compliance in the eStar Era + Manufacturing Warning Letter
Watch now (36 mins) | IND safety reporting guidance, prevent format holds in medical device submissions, and a warning letter that shows what happens…
Feb 2
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The FDA Group
2
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
•
The FDA Group
15
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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