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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
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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
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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
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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
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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
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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
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The FDA Group
5
2
The FDA Opens Submissions for PreCheck
What the new program means for U.S. drug manufacturing.
Feb 6
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The FDA Group
5
1
[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Watch now (33 mins) | A Bayesian methodology draft guidance for clinical trial design, a finalized RWE framework for medical devices, and a Georgia…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
32:41
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
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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
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The FDA Group
3
1
[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
35:54
[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
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The FDA Group
2
29:44
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