Best of February: Top 5 Insights In Drug Formulation & Delivery

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

In this article, Fran DeGrazio comments on the FDA draft guidance on Use-Related Risk Analysis (URRA) in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA.

#2 - Understanding CGMPs For Combination Products

Susan Neadle, and chapter co-author Mike Wallenstein share their perspectives on combination product CGMP’s, including regulatory definitions and differences in the U.S. and Europe, supplier controls, design controls, and manufacturer responsibilities.

#3 - Only DTx In Drug Delivery Can Take Us To The Next Level Of Diabetes Care

The convergence of advanced technologies and advancements in drug delivery is reshaping diabetes care. Digital therapeutics (DTx) deliver therapeutic interventions driven by high-quality software and mobile applications.

#4 - Exploring Progress In Nanomedicine: Unlocking New Possibilities For Treating Rare Genetic Diseases

Gene therapy offers hope for rare genetic diseases, with advancements in polymer nanoparticles addressing delivery challenges and paving the way for innovative, effective treatments.

#5 - mRNA Empowering Engineered In Vivo Cell Therapies

Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy.