Best of 2025: Top 10 Insights In Drug Formulation & Delivery

#1 - Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective

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.

#2 - Developing A Combination Product: Early-Stage Formulation And Device Considerations At GSK

In this episode of In Combination, host Tom von Gunden combines the perspectives of three functional area leads who work collaboratively during early-stage product development and device selection at GSK.

#3 - Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3

This article compares U.S. FDA and EU EMA regulatory requirements for drug–device combination products, highlighting key differences in terminology, review pathways, and CTD Module 3 structure, while showing that the underlying data expectations are largely aligned.

#4 - Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery

Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.

#5 - Use-Related Risk Analysis: Considering The FDA Guidance On URRA

Learn how to apply the FDA draft guidance on Use-Related Risk Analysis (URRA) effectively, avoid overdocumentation, and strengthen your regulatory strategy for drug, biologic, and combination products. 

#6 - Managing Risk When Developing Combination Products

In this episode of The Combination Products Handbook: The Series, the book’s editor, Susan Neadle, and chapter co-author Edwin Bills share their perspectives on the centrality of risk management and patient safety to pre-market and post-market considerations during combination product development and commercialization.

#7 - The Future Of Biologics Delivery: High-Concentration Subcutaneous Injectables

Discover how the rapid growth of biologics is driving a shift away from IV infusions to high-concentration subcutaneous injectables, and learn how emerging subcutaneous delivery technologies can expand patient access, relieve healthcare system strain, and shape the future competitive landscape for biologics.

#8 - Sample Sizes For Performance Testing Of Combination Products And Drug Packaging

Learn how to determine statistically meaningful sample sizes for performance testing of combination products and drug packaging, aligning risk, reliability, and confidence levels with global standards. Gain practical guidance on selecting the right sample sizes and strengthening your design verification strategy for regulatory success.

#9 - The Technologies Propelling GLP-1 Analogues

Examine the technologies driving the rapid growth of GLP-1 analogues, from advanced manufacturing and hybrid synthesis methods to novel drug delivery platforms. Explore how these innovations are improving scalability, bioavailability, and patient convenience while shaping the future of the booming GLP-1 market.

#10 - Broadening The Range Of Self-Administered Biologics With Stevanato Group's Riccardo Butta

In this episode of Supplier Horizons, host Tom von Gunden talks with Stevanato Group’s President, Americas, Riccardo Butta about the convergence of human factors and device design during platform development for injectable and on-body delivery systems.