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insider.thefdagroup.comLatest Issues
8 Lessons From a Site Quality Audit With Multiple Findings
We recently ran a quality audit of a manufacturing site that turned up multiple findings, four of them repeats. Here's what the findings, and the site's own responses, can teach other teams.
Our last audit lessons piece came from a contrac...
Guidance Breakdown: FDA Proposes eSTAR for IDEs
CDRH and CBER issue their first draft guidance on electronic submission templates for Investigational Device Exemption applications.
This guidance breakdown is available in full to paid subscribers. Only paid subscribers get regular full a...
Pharma Tech Transfer Is Knowledge Transfer, with Paige Kane, PhD, CPIP
Subscribe to our podcast, The Life Science Rundown, if you haven’t already.
If everything a receiving site needed were in the transfer documents, Paige Kane points out, you could probably pull off a technology transfer through FedEx.
But...
Pharma Tech Transfer Is Knowledge Transfer
Why does tech transfer remain so hard in pharma , even when every document is neatly in order? Paige Kane, PhD, CPIP, Associate Vice President of Technical Excellence & Transformation at CAI, has spent about 25 years on technology transfers...
Guidance Breakdown: FDA Revises Its Small Entity Guide on IND and BA/BE Safety Reporting
The October 2026 revision adds no new requirements. What it does is confirm which guidances are current, and that two guidances your safety SOPs may still cite have been withdrawn.
This guidance breakdown is available in full to paid subsc...
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