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| Platform |  | Pricing | Freemium | Publishes | Daily |
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insider.thefdagroup.comLatest Issues
Scoping the Real Risk of Data Integrity Issues in an Out-of-the-Box eQMS
We recently shared some observations on how a new eQMS can be underbuilt for the stage a company is entering. Today, we have an actual case study that shows what that risk looks like in a real operation.
A clinical-stage biotech approached...
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
Subscribe to our podcast, The Life Science Rundown, if you haven’t already.
With so many new subscribers now coming to the newsletter each week, we’re resharing one of our favorite conversations from a few years back.
We’re bringing it b...
[May 2026] FDA's NAMs Validation Framework, Finalized Patient Preference Information Guidance + Clinical Thermometer Warning Letter
Watch now (74 mins) | CDER tells you how to put new approach methodologies in front of reviewers, FDA finalizes guidance on patient preference information across the product life cycle, plus a warning letter breakdown.
Welcome to Insider i...
A Quick Explainer on the FDA's Leadership Shakeups
There's been a lot happening. Here's a simple guide for catching up with recent personnel changes.
It’s been hard to keep up with all the personnel changes at the FDA recently. In the last few weeks alone, the agency has lost its commissio...
Where Your Out-of-the-Box eQMS is Probably Underbuilt
A few of the configuration gaps we see that cause compliance problems later, and where to close them.
We’ve been seeing a specific situation pretty regularly: a growing clinical-stage firm discovers that the eQMS it bought maybe two years...
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
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