Featured Editorial

1. The Companion Diagnostic Strategy That Combination Product Leaders Need 9/17/2025

   In the U.S., the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.

2. Beyond The Inhaler: Expanding COPD Care With Nebulized Combination Therapy 9/3/2025

   Seventy-five percent of COPD patients can't use inhalers properly — yet all therapies rely on handheld devices. Nebulized combinations could bridge this gap for those who need it most.

3. 7 Management Strategies For Combination Product Regulatory Success 9/2/2025

   In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success. 

4. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

   The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

5. Improving Drug-Device Combination Product Co-Development 8/8/2025

   Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

6. Delivering Therapies To The Olfactory Region 8/7/2025

   Olfactory loss presents a unique set of challenges. Cyrano is developing a spray technology with a soft mist, specific droplet size, and low velocity to reach the upper nasal cavity.

7. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

   Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

8. Understanding Annex 1 For Sterile Medicinal Products 8/4/2025

   In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training. 

9. All Of Us Need To Be Rooting For The FDA 7/23/2025

   In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

10. New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development 7/3/2025

    The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase.