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Why Embedding a Senior Quality Consultant Can Be the Fastest Way to Regain Control
When you have a backlog growing faster than your team can close it, the answer isn't always hiring. Sometimes it's deploying the right person to embed…
19 hrs ago
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The FDA Group
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Guidance Breakdown: FDA Finalizes Updated Guidance on Patient Preference Information
The agency's new guidance expands the role of voluntary patient preference data across the entire device lifecycle. Here are the 12 key points we pulled…
Mar 31
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The FDA Group
5
Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
What it takes to align three major regulators on a single development program, and why treating ICH compliance as hard regulatory alignment is a…
Mar 30
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The FDA Group
2
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28:53
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
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The FDA Group
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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
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The FDA Group
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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
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The FDA Group
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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
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The FDA Group
10
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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
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The FDA Group
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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
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The FDA Group
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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
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The FDA Group
3
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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
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The FDA Group
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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
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The FDA Group
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