Featured Pharma Online Editorial

1. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

   The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

2. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

   Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

3. 3 [Potential] Solutions To A More Resilient Supply Chain 10/16/2025

   In her opening presentation, Harney noted that there were 98 drug shortages in 2024, 40 medicines in shortage for over three years, and the average duration of a shortage has increased from three years to four years.

4. Import Product Specifications And Drug Registration Testing For China 10/6/2025

   This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

5. Derisking AI Means First Asking: Who Does It Serve? 9/26/2025

   Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.

6. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

7. Operating And Maintaining Pharmaceutical Gas Distribution Systems 9/12/2025

   Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.

8. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

   The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

9. FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries 8/29/2025

   The 2024 Report on the State of Pharmaceutical Quality shows the agency's efforts to normalize post-pandemic oversight under the previous administration.

10. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.