The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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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…
 • The FDA Group
QSIT is Officially Replaced: What FDA’s New Inspection Program Means Under QMSR
Effective today, FDA medical device inspections will no longer be conducted under the Quality System Inspection Technique (QSIT).
 • The FDA Group
FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses
A new data study reveals what we've seen firsthand: the FDA isn't slowing down reviews even after trimming its staff significantly.
 • The FDA Group
FDA Removes a Major Barrier to Using Real-World Evidence in Regulatory Reviews
The agency says it will now evaluate real-world evidence on a case-by-case basis, removing long-standing requirements for identifiable patient-level…
 • The FDA Group
4 Drug GMP Takeaways From FDA's 2025 Warning Letters
And how QA teams should operationalize the data to strengthen compliance now.
 • The FDA Group
CDER Warning Letters Jump 50% in FY 2025 — What That Means for Industry
FDA enforcement is accelerating. The latest data shows where the agency is focusing and what companies should be preparing for now.
 • The FDA Group
A Quick Explainer on the Tidmarsh Drama at the FDA
A high-stakes power struggle inside the FDA has spilled into public view.
 • The FDA Group
How the Shutdown is Affecting the FDA
Another shutdown leaves the FDA balancing public health responsibilities against frozen funding. Here’s what continues, what stops, and what it means…
 • The FDA Group
Innovative Product Approval Showcase: A Quick Mid-Year Roundup
From precision oncology breakthroughs to patient-driven diagnostics, here are some of the FDA’s most impactful approvals of 2025 so far.
 • The FDA Group
The FDA Announces PreCheck: A Fast-Track for Building U.S. Drug Plants
A new two-phase “PreCheck” pathway could shave months off U.S. plant construction while turning early regulatory engagement into a competitive edge for…
 • The FDA Group
Streamlining Drug Safety: A Look at FDA's New Framework for Smarter Clinical Trial Data Collection
The CDER just published a new white paper on Selective Safety Data Collection. We dissect it.
 • The FDA Group
Trump Gives Medical Device Sterilizers Two More Years to Comply with EtO Limits
President Donald Trump issued an executive order granting a two-year extension for medical device sterilization facilities to comply with the new limits…
 • The FDA Group
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