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Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions
Mar 11
•
The FDA Group
15
2
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
Apr 14
•
The FDA Group
18
2
5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
Jun 26, 2025
•
The FDA Group
16
1
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Apr 22, 2025
•
The FDA Group
8
34:57
Is Your Biotech De-Risking or Just Delaying?
Baseimmune's CEO Kevin Walton on beachhead decisions, why accumulating supportive data can be a form of procrastination, and what’s actually getting…
Sep 18
•
The FDA Group
6
1
Is Your Biotech De-Risking or Just Delaying?
What stops a promising platform from becoming an investable company?
Sep 18
•
The FDA Group
34:57
The FDA's Expedited IND Pilot Is Live
The agency published the final design and opened applications. Eight to ten sponsor-institution pairs will be selected.
Sep 15
•
The FDA Group
6
1
1
A Few Best Practices for Scheduling GxP Audits
We talked to our account managers and auditors to surface the things the people who build these schedules and go to these sites wish more teams did.
Sep 15
•
The FDA Group
5
1
Reg Ops Has Been Kept in a Box. This Is the Way Out, with Carla Griffin
Why FDA's real-time clinical trials work is an opportunity for regulatory operations professionals rather than a threat, and what to do in the next…
Sep 14
•
The FDA Group
7
1
24:00
24:00
Reg Ops Has Been Kept in a Box. This Is the Way Out.
As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals?
Sep 14
•
The FDA Group
1
41:40
[August 2026] FDA's New Rulebook for Formal Meetings, Human Factors Harmonized with QMSR + A Warning Letter Under the New Device Rule
The FDA rewrites how sponsors request meetings during drug development, folds human factors into the quality system, and posts a warning letter written…
Sep 11
•
The FDA Group
8
1
RA/QA News Roll: Late August 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 10
•
The FDA Group
4
1
The FDA Just Signaled It Will Throw Out Foreign Trial Data It Can’t Verify
Four center directors signed a joint statement on GCP and foreign clinical data. No new requirements, but it’s important for how you select sites.
Sep 4
•
The FDA Group
10
1
28:11
QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
Why late QA involvement doesn't just cost money, it removes your cheap options. And what phase-appropriate quality actually looks like now from…
Sep 1
•
The FDA Group
4
1
28:11
QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
How do biotech companies move QA from late-stage gatekeeper into an early, risk-appropriate technical partner?
Sep 1
•
The FDA Group
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…
Aug 28
•
The FDA Group
5
1
7 Audit Program Planning Moves to Make in Q3
A quick checklist for Quality teams putting their 2027 audit schedule together.
Aug 27
•
The FDA Group
5
1
See all
RA/QA News Rolls
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RA/QA News Roll: Late August 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 10
•
The FDA Group
4
1
RA/QA News Roll: Mid August 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Aug 23
•
The FDA Group
4
RA/QA News Roll: Late July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Aug 7
•
The FDA Group
9
1
RA/QA News Roll: Mid July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jul 21
•
The FDA Group
5
1
FDA News
View all
The FDA's Expedited IND Pilot Is Live
The agency published the final design and opened applications. Eight to ten sponsor-institution pairs will be selected.
Sep 15
•
The FDA Group
6
1
1
The FDA Just Signaled It Will Throw Out Foreign Trial Data It Can’t Verify
Four center directors signed a joint statement on GCP and foreign clinical data. No new requirements, but it’s important for how you select sites.
Sep 4
•
The FDA Group
10
1
Trump Nominates Heidi Overton for FDA Commissioner
What we know so far, and what it may signal about the agency's direction.
Aug 19
•
The FDA Group
4
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
Podcast
View all
34:57
Is Your Biotech De-Risking or Just Delaying?
Baseimmune's CEO Kevin Walton on beachhead decisions, why accumulating supportive data can be a form of procrastination, and what’s actually getting…
Sep 18
•
The FDA Group
6
1
24:00
Reg Ops Has Been Kept in a Box. This Is the Way Out, with Carla Griffin
Why FDA's real-time clinical trials work is an opportunity for regulatory operations professionals rather than a threat, and what to do in the next…
Sep 14
•
The FDA Group
7
1
28:11
QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
Why late QA involvement doesn't just cost money, it removes your cheap options. And what phase-appropriate quality actually looks like now from…
Sep 1
•
The FDA Group
4
1
1:00:05
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…
Aug 27
•
The FDA Group
6
Deep Dives
View all
41:40
[August 2026] FDA's New Rulebook for Formal Meetings, Human Factors Harmonized with QMSR + A Warning Letter Under the New Device Rule
The FDA rewrites how sponsors request meetings during drug development, folds human factors into the quality system, and posts a warning letter written…
Sep 11
•
The FDA Group
8
1
41:45
[July 2026] ANDA Postapproval Requirements Consolidated, a Device Warning Letter About Broken Feedback Loops + Aseptic Filling Basics…
The FDA pulls the boilerplate out of ANDA approval letters and puts it in one place and cites a firm for a quality system that saw the hazard in one…
Jul 31
•
The FDA Group
17
1
50:08
[June 2026] CMC Flexibility for Cell and Gene Therapy, Finalized Human Factors Submission Guidance + a Data Integrity Warning Letter
The FDA loosens CMC requirements for cell and gene therapy products, publishes a yes/no flowchart that right-sizes human factors submissions, and we…
Jul 1
•
The FDA Group
7
1
1:14:09
[May 2026] FDA's NAMs Validation Framework, Finalized Patient Preference Information Guidance + Clinical Thermometer Warning Letter
CDER tells you how to put new approach methodologies in front of reviewers, FDA finalizes guidance on patient preference information across the product…
May 27
•
The FDA Group
7
1
Audit Trend Reports
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What Our Auditors Are Finding Lately: 7 Trends Across GMP, GLP, GCP, and Device Work (Q2 2026)
A quarter's worth of supplier qualifications, mock inspections, vendor re-quals, and internal audits, read back to back.
Jul 23
•
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
17
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
AICA
View all
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…
Aug 28
•
The FDA Group
5
1
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!
Aug 17
•
The FDA Group
4
1
3:15
A Warning Letter Citation AICA Likely Would Have Flagged
A quick look at how AICA might have caught the indicators of a real FDA warning letter citation in its reports.
Aug 3
•
The FDA Group
7
2
AICA in the Quality Department: How to Actually Use it Day to Day
Where our AI-powered auditing tool fits in the everyday work of a Quality team.
Jun 25
•
The FDA Group
3
1
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