Inhalation Drug Delivery Articles

1. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

   The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

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   The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.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. A Promising Approach To Develop An Inhalable, Temperature-Stable COVID-19 Vaccine 4/12/2024

   There are limitations to the currently available COVID-19 vaccines. An inhalable dry powder approach offers promising benefits, such as eliminating cold chain requirements, allowing for more widespread immunity.

7. 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.

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. Tackling 3 Challenges In Developing An Inhaled Gene Therapy 1/5/2024

    Inhalers hold great potential for delivery of high concentrations of gene therapy directly into the lung. This article shares the experiences of a team who have worked on the development of a gene therapy to treat cystic fibrosis.