Featured Pharma Online Editorial

1. The Orange Book's Blind Spot: Process Stability And Capability 10/5/2026

   The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.

2. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

3. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

   Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

4. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

   The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

5. ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions 9/28/2026

   A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

6. 4 Ways To Build A Better CMC Tech Transfer 9/23/2026

   A technology transfer can falter long before a process reaches the plant. Gaps in process knowledge, mismatched equipment, and insufficient scale-up data can all undermine reproducibility, timelines, and cost.

7. US Pharma Reshoring: The Full Policy Timeline 9/17/2026

   As policy shifts and manufacturing investments reshape pharma supply chains, capacity constraints and global dependencies persist. Explore the implications for long-term resilience.

8. The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem 9/17/2026

   The wrong regulatory filing sequence can close faster pathways, delay importation, and consume shelf life. Here’s how regulatory strategy can reshape clinical supply.

9. What FDA Inspectors Want From Your OOS File 9/16/2026

   Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.

10. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.