Inhalation Drug Delivery Articles

41. 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.

42. 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.

43. 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.

44. 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.

45. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3 12/20/2023

    This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.

46. Key Regulatory-Fueled Updates On Combination Products As We Enter 2024 12/15/2023

    In late November, AFDO/RAPS held their annual Combination Products Summit in Fort Worth, TX. The meeting is co-sponsored by the FDA with heavy involvement from the Office of Combination Products, and its representatives covered several themes on the subject as we prepare to enter 2024.

47. Human Factors Considerations For Your Emergency Use Drug Delivery Device 11/27/2023

    Emergency use medical devices have seen the autoinjector EpiPen leading the way, followed by the emergence of naloxone nasal sprays and autoinjectors for the treatment of opioid overdose, and others. There are use-related challenges in emergency situations, so you will need to give careful consideration to the human factors involved with who is using the device and how it is accessed.

48. How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products 11/16/2023

    This article shares pro tips related to usability studies, design controls, and other human factors engineering best practices to make the FDA happy with your combination product.

49. FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products 10/31/2023

    Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.

50. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2 10/27/2023

    This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.