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LATEST
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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
9
1
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Apr 22, 2025
•
The FDA Group
8
A Few Quick Tips for CAPA System Success in 2025
Jan 22, 2025
•
The FDA Group
15
FDA Warning Letter Breakdown: Sterility Failures, Subpotent GLP-1 Drugs, and a Compounding Pharmacy Operating Without Control
When compounded semaglutide and tirzepatide fail sterility and potency testing, and get distributed anyway, the implications extend far beyond one…
Feb 19
•
The FDA Group
4
1
Inside Our Quality Backlog Reduction Playbook
The methodology we use when backlogs become a crisis. Here's how to dig out and stay out.
Feb 17
•
The FDA Group
6
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
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
37:59
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
15 Takeaways from FDA's QMSR Implementation Webinar
RAPS recently hosted an online session on bringing QMSR compliance to life with the FDA’s lead for QMSR implementation. We distilled the practical…
Feb 6
•
The FDA Group
5
2
The FDA Opens Submissions for PreCheck
What the new program means for U.S. drug manufacturing.
Feb 6
•
The FDA Group
5
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Watch now (33 mins) | A Bayesian methodology draft guidance for clinical trial design, a finalized RWE framework for medical devices, and a Georgia…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
QMSR is Here: What the New Rule and Compliance Program Mean for Device Manufacturers
The FDA's new quality system regulation and compliance program are now in effect. Here's what the new framework looks like, who's most at risk, and what…
Feb 3
•
The FDA Group
3
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
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
57:15
[November 2025] Alternative Facility Assessment Tools, Computer Software Assurance + Warning Letter Breakdown
Watch now (57 mins) | FDA's guidance on alternative assessment tools for drug facilities, the new risk-based software validation framework, and a…
Feb 2
•
The FDA Group
2
See all
RA/QA News Rolls
View all
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
RA/QA News Roll: Mid January 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Jan 15
•
The FDA Group
3
1
RA/QA News Roll: Mid December 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Dec 17, 2025
•
The FDA Group
1
1
FDA News
View all
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
15 Takeaways from FDA's QMSR Implementation Webinar
RAPS recently hosted an online session on bringing QMSR compliance to life with the FDA’s lead for QMSR implementation. We distilled the practical…
Feb 6
•
The FDA Group
5
2
The FDA Opens Submissions for PreCheck
What the new program means for U.S. drug manufacturing.
Feb 6
•
The FDA Group
5
1
QMSR is Here: What the New Rule and Compliance Program Mean for Device Manufacturers
The FDA's new quality system regulation and compliance program are now in effect. Here's what the new framework looks like, who's most at risk, and what…
Feb 3
•
The FDA Group
3
Podcast
View all
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
35:24
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.
Jan 12
•
The FDA Group
5
1
42:34
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.
Jan 6
•
The FDA Group
5
1
Deep Dives
View all
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
57:15
[November 2025] Alternative Facility Assessment Tools, Computer Software Assurance + Warning Letter Breakdown
Watch now (57 mins) | FDA's guidance on alternative assessment tools for drug facilities, the new risk-based software validation framework, and a…
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
9
1
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