Transdermal Drug Delivery Articles

1. 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.

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   The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

3. 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.

4. Breaking Through The Blood–Brain Barrier: The Rise Of Focused Ultrasound 4/5/2024

   Focused ultrasound can noninvasively, safely, and reversibly open the blood–brain barrier, overcoming a major obstacle for therapies targeting neurodegenerative diseases. Here's how.

5. 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.

6. 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.

7. 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.

8. Liposome Drug Delivery: Global Trends & Market Forecast 1/19/2024

   Liposomes possess the ability to encapsulate drugs of both hydrophilic and hydrophobic nature. They can be tailored to target tissues or cells, enabling precise drug delivery. Let's examine how it works, applications, and new market insights.

9. FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance 11/2/2023

   As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.

10. Emerging Market Trends For Drug Delivery Devices 10/5/2023

    The market for drug delivery devices is growing and it is estimated to reach a market size of $541.5 billion by 2035. This article shares new market research, including segmentation by product type (inhalers, smart pills, drug-eluting stents, and more), routes of administration, regional analysis, and more.