Injectable Drug Delivery Articles

1. A Holistic Approach To Container Closure Integrity 5/20/2024

   Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

2. A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices 5/8/2024

   Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.

3. How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint 4/29/2024

   EU MDR has raised the bar compared to other jurisdictions in areas such as stronger emphasis on collecting pre- and post-market data. If you align your operating model for EU compliance, you'll be in a better position to enter other markets.

4. Long Live Design Controls: Navigating The Shift From QSR To QMSR 4/22/2024

   The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

5. Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms 4/16/2024

   Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.

6. New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis 2/29/2024

   On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

7. Exploring Biolistic Particle Delivery Systems 2/29/2024

   The main objective of biolistic particle delivery is to insert genetic material or other molecules into cells or tissues for diverse applications, including genetic engineering, gene therapy, and plant modification. The ability to target substances into specific cells enables researchers to investigate gene functionality, alter genetic traits, or explore novel therapeutic strategies.

8. Use-Related Risk Analysis For Combination Products 2/7/2024

   One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.

9. Foundational Human Factors Engineering Concepts For The Design Of Combination Products 2/5/2024

   How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.

10. Auto-injectors: Global Trends & Market Forecast 1/30/2024

    Auto-injectors offer a dependable method for delivering medication, especially during emergency scenarios. This article shares new market research, including macro trends, smart features, disposable vs. reusable trends, and more.