The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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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.
 • The FDA Group
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…
 • The FDA Group
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.
 • The FDA Group
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…
 • The FDA Group
The FDA Opens Submissions for PreCheck
What the new program means for U.S. drug manufacturing.
 • The FDA Group
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
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