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Resources > Articles
Regulatory Intelligence,
In Depth.
Articles, whitepapers, guides, and case studies for Life Sciences regulatory professionals navigating a faster, more complex regulatory world.
ICH Q9(R1) in Practice: Formality, Subjectivity and What Inspectors Now Expect
What ICH Q9(R1) changed in quality risk management: subjectivity, formality, risk-based decisions and product availability, with worked examples and a practical framework.
Sep 228 min read
Nitrosamine and NDSRI Control After the August 2025 Deadline: Where FDA and EMA Stand
Where nitrosamine and NDSRI control stands after FDA's August 2025 progress report change: CPCA limits, EMA Article 5(3) Q&A, mitigation and submission pathways.
Sep 229 min read
FDA Premarket Cybersecurity Under Section 524B: What Reviewers Expect in 2026
What FDA requires for cyber devices under Section 524B: the cyber device definition, SBOMs, threat models, testing, postmarket plans and the February 2026 guidance update.
Sep 229 min read
510(k) vs. De Novo vs. PMA: Choosing the Right FDA Pathway
Every medical device company reaches the same fork in the road: which FDA pathway fits the device in front of them. Choosing wrong doesn’t just cost time — it can mean building an entire evidence package for the wrong evidentiary standard, then rebuilding it under regulatory pressure. This article walks through how the three primary pathways — 510(k), De Novo, and PMA — actually differ in practice, and how sponsors should be thinking about the decision in 2026. The Core Disti
Sep 224 min read
The Human Factors Compliance Clock Just Ran Out
FDA's final Human Factors guidance takes effect this week. Here's what changed in the eSTAR template and what to check in your submission pipeline now.
Jul 273 min read
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