The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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A Few Thoughts on How FDA's AI-Powered Risk Targeting with Elsa Could Change Inspection Readiness
The FDA says its new AI tool, Elsa, can now help pinpoint inspection targets faster and more precisely—here’s what firms might want to start thinking…
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The FDA Group
FDA Launches Its AI Tool 'Elsa' Ahead of Schedule to Enhance Agency Operations
The FDA says its new large language model–powered tool is already accelerating reviews, aiding inspections, and supporting database development as part…
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The FDA Group
Are Workforce Cuts Slowing Down the FDA? Here's What Our Consultants Are Seeing
Anecdotes from the field reveal a complex, uneven picture of how FDA’s internal upheaval is playing out in practice at the moment.
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The FDA Group
Our 7 Takeaways from the New MAHA Report
The White House published its MAHA commission report, outlining key priorities of the Trump administration for transforming the US healthcare system and…
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The FDA Group
The FDA Plans to Roll Out AI for Reviews This Summer — Here's What to Know
The agency just set an "aggressive timeline" for AI Implementation after a successful pilot. Here's what to start thinking about now.
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The FDA Group
Tracking Major Changes at the FDA: May 13
Policy shifts, AI rollouts, reappointments, and legal backlash.
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The FDA Group
Unannounced FDA Foreign Inspections Expand as Administration Pushes Domestic Manufacturing
Domestic manufacturing is about to get fast-tracked while foreign facilities face surprise inspections. Are you ready?
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The FDA Group
Tracking Major Changes at the FDA: April 25
The agency faces database setbacks, leadership changes, and legal challenges as staff cuts reshape regulation and enforcement.
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The FDA Group
Tracking Major Changes at the FDA: April 18
A leaked HHS budget reveals major FDA cuts, layoffs delay pediatric policy meeting, and biotech firms report review slowdowns.
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The FDA Group
Tracking Major Changes at the FDA: April 10
Agency reorganization effects, tariffs for pharma, and biotech CEOs reporting FDA disruptions.
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The FDA Group
Tracking Major Changes at the FDA: April 9
VAERS drama, executive firings, and a shrinking budget.
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The FDA Group
Tracking Major Changes at the FDA: Insiders Say Inspection Operations Could Be Impacted by Layoffs
The FDA is planning for fewer food and drug inspections due to layoffs, officials say.
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The FDA Group
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