Featured Pharma Online Editorial

1. Experts' Advice On Facility Design And Construction 4/24/2025

   This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

2. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

   Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

3. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

   Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

4. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

5. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

6. Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting 4/16/2025

   Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.

7. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

   In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

8. Oral Therapies Take Center Stage For PsO And PsA Treatment 4/1/2025

   The recent American Academy of Dermatology 2025 Annual Meeting in early March saw major updates for two key oral therapies in autoimmune diseases.

9. AI Model Cards Make Function And Risk Easier To Understand 3/31/2025

   AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

10. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

    The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.