Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
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Electronic Regulatory Submissions Part 12
CTD Organization Makes Finding Information Simpler (Note: This post is part of a multi-part series on the CTD this fall) Part of what makes the CTD so useful is its internal structure. We can look at the Quality Overall Summary (QOS) as an example (see the M4Q...
Electronic Regulatory Submissions Part 11
What’s in Module 5 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 5 contains the clinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 5 and 6. Module 5...
Electronic Regulatory Submissions Part 10
What’s in Module 4 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 4 contains the nonclinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 4and 6,...
Electronic Regulatory Submissions Part 9
What’s in Module 3 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 3 of the CTD contains the Quality data, which is the detailed information on the chemistry, manufacturing process, and control strategy for both the drug...
The 21st Century Cures Act Changed What is Considered a Device
Check out new guidance and webinar for details As I’ve previously mentioned, section 3060 of the 21st Century Cures Act specifically exempts certain types of software functions from FDA regulatory oversight as medical devices. CDRH has issued the final level 1...