Transdermal Drug Delivery Articles

1. Drug Delivery Product Strategy: Aligning The Organization For Execution 10/1/2025

   In this article, Fran DeGrazio offers recommendations to biopharmaceutical sponsor companies about best practices for aligning strategic product initiatives with functional area execution. She outlines 5 key considerations, illustrated with the increasingly common market strategy expansion from drug product development to drug-device combination product delivery.

2. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

   One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

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. 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. 

5. 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. 

6. 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. 

7. Drug Delivery Innovation: If You Build It, Will Anyone Care? 7/1/2025

   In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace. 

8. 3 Lesser Known Keys To Effective Biopharma Supplier Engagement 6/4/2025

   In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services. 

9. Tips From A Biomedical Engineer For Medical Device Innovation And Compliance 5/20/2025

   Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

10. Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective 5/1/2025

    In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.