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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
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
Sep 10, 2025
•
The FDA Group
10
1
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Apr 22, 2025
•
The FDA Group
8
A Podcast Appearance Leads to a Warning Letter for a Biologics Developer
The FDA issued a warning letter over a TV ad and a podcast appearance by its executive chairman, citing false cure claims, missing risk information, and…
Mar 25
•
The FDA Group
6
2
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
2
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
Hosting a GMP Audit: Three Places We See Preparation Gaps (and How to Close Them)
We asked a few of our auditors where they see teams fall down the most on audit logistics.
Mar 20
•
The FDA Group
10
2
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
32:46
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
2
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
AICA's Security Architecture: What Your IT Team Needs to Know
The technical details behind how AICA handles your data (written for the people who have to approve it).
Mar 16
•
The FDA Group
4
1
Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions
Three CDER warning letters posted March 10 expose a shared enforcement theme: inadequate responses, systemic quality failures, and a regulator losing…
Mar 11
•
The FDA Group
15
2
A Few Use Cases for AICA
Here's how AICA, our new AI-powered compliance auditing tool, fits into the work you're already doing.
Mar 11
•
The FDA Group
5
FDA Warning Letter Breakdown: Missing the Basic Requirements of Clinical Research
A clinical site collected samples from a subject who declined consent twice. The FDA's issue wasn't just the mistake, it was the response.
Mar 10
•
The FDA Group
10
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
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
See all
RA/QA News Rolls
View all
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
2
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
RA/QA News Roll: Late January 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Feb 2
•
The FDA Group
3
1
FDA News
View all
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
2
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
Industry Pushes for Automatic Post-Inspection Meetings and Faster FDA Response Times
What the January CMC subgroup discussions reveal about potential changes to the Form 483 process amid PDUFA VIII negotiations.
Feb 9
•
The FDA Group
4
1
Podcast
View all
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
28:05
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…
Mar 5
•
The FDA Group
4
1
37:59
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.
Feb 10
•
The FDA Group
3
1
29:09
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…
Jan 20
•
The FDA Group
8
1
Deep Dives
View all
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
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
•
The FDA Group
2
29:44
[December 2025] Biosimilar CES Guidance, QMSR Pre-Market Submission Requirements + Warning Letter
Watch now (30 mins) | FDA guidance that could cut months from biosimilar BLA timelines, what FDA expects in QMS documentation for 510(k)s and a warning…
Feb 2
•
The FDA Group
2
Audit Trend Reports
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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