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Embedding a Clinical QA Consultant for Phase 3 QMS Development
Six months to inspection-ready. Here's a look inside the clinical QMS build that took a small sponsor from Phase 2 success to Phase 3 first patient…
May 14
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The FDA Group
4
1
5 Things We Commonly Find in SOP Gap Analyses
Specific findings differ from one procedure to another, but a few overarching gaps tend to be the same.
May 12
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The FDA Group
9
1
The FDA's One-Day Inspection Pilot Is Already Running
What we know about the new "inspectional assessments."
May 7
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The FDA Group
3
1
Guidance Breakdown: FDA Formalizes CMC Flexibilities for Cell and Gene Therapy Products Heading Toward BLA
A quick breakdown of CBER's final guidance on CMC flexibilities for human CGT product development.
May 6
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The FDA Group
8
1
How Contracted Insourcing is Making Clinical Operations More Efficient
More sponsors are embedding consultants directly into their ClinOps functions as a faster, more flexible alternative to FTEs or full outsourcing. Here's…
May 5
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The FDA Group
2
1
More OMQ Letters After FDA Inspections? Don't Treat Them as Noise
We're hearing that manufacturers are getting more post-inspection mail from CDER. Here's what the letters actually mean for your next inspection.
May 4
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The FDA Group
5
2
What Keeps Good Companies From Becoming Great?
Peter Martino on vision, focus, and the discipline of doing less.
May 2
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The FDA Group
3
28:53
How to Write Better IQ, OQ, PQ Protocols
Most qualification protocols we review are too vague. Here's how to fix them.
May 1
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The FDA Group
10
2
RA/QA News Roll: Late April 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
May 1
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The FDA Group
3
April 2026
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.
Apr 30
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The FDA Group
7
2
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.
Apr 30
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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
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The FDA Group
15
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