Featured Pharma Online Editorial

1. 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.

2. 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.

3. 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.

4. Building Trust In AI For Computerized System Validation 9/4/2026

   Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

5. When To Trust And When To Verify AI-Enabled Validation Systems 9/3/2026

   Computer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.

6. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

   Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

7. AI Governance Is Just Like Driving A Race Car 9/1/2026

   Though some skeptics remain, nearly every business is at some stage of AI adoption. The technology has proven applications in pharmaceutical manufacturing, but effective governance must keep pace with its rapid development. That challenge is familiar to Bill Reid, healthcare and life sciences lead in Google’s Chief Information Security Office (CISO).

8. Controls For Retrieval-Augmented Generation In GxP 9/1/2026

   Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.

9. FDA Issues New Guidance On Therapeutic Equivalence 9/1/2026

   The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

10. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.