Transdermal Drug Delivery Articles

1. Crossing The Uncrossable: Skin Biology For The Delivery Of Peptide And Protein Therapeutics 10/14/2026

   The skin excludes water-soluble macromolecules from getting through. Delivery science has answered not by defeating the barrier but by dismantling specific mechanisms. Let's take a closer look.

2. When The Adhesive Becomes The Drug Delivery System 10/13/2026

   The adhesive is not the component that keeps the patch on the patient. It is the formulation, and the physical state of the drug inside it is a design choice whether or not anyone makes it deliberately. 

3. Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions 10/8/2026

   Teams must assess the drug, the device, the manufacturing process, and the environment in which the product is used as an integrated system, not as separate parts. 

4. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

   The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

5. Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations 9/1/2026

   In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes. 

6. Delivery Device Functional Scrutiny: Can You Pass (Without) The Test? 7/13/2026

   In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).  

7. Stability And Release Testing For Delivery Devices: Waived Or Wanted? 7/13/2026

   In this article, combination product consultant Doug Mead reports on precedent research he conducted on requests for FDA waivers on functional stability and release testing for drug delivery devices. He provides sample scenarios in the context of device design considerations for Essential Performance Requirements (EPRs) and the more recent FDA draft guidance on Essential Drug Delivery Outputs (EDDOs).

8. Microneedles In Drug Delivery: From Bench To Patch 7/10/2026

   Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.

9. Improving Execution Of Biological Evaluation Of Drug Delivery Devices 6/3/2026

   This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.

10. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

    The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.