Inhalation Drug Delivery Articles

1. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

   FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

2. 5 Top-Of-Mind Drug Delivery Topics In 2024 12/3/2024

   In this article, Fran DeGrazio highlights five drug delivery challenges that were commonly discussed by industry insiders throughout 2024. With particular focus on combination products, these key themes included supplier qualification, cross-functional product development, platform approaches, patient self-administration, and regulatory considerations.

3. We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead 11/13/2024

   The EU Commission had issued an extension to manufacturers to sign up with a notified body for EU Medical Devices Regulation (MDR) compliance, but instead, manufacturers have slowed down compliance activities, resulting in an upcoming bottleneck of approvals.

4. 5 Areas Of Drug Delivery Innovation To Watch In 2025 11/12/2024

   2024 has seen some promising advances in drug delivery technology. Strategic pharma/biotech companies may wish to seize these opportunities for their drug candidates in 2025.

5. How Does Robotics Aid Occlusion Testing For Drug Delivery Devices? 11/5/2024

   Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.

6. Understanding Essential Drug Delivery Outputs: Things To Know About EDDOs 11/5/2024

   The FDA draft guidance on Essential Drug Delivery Outputs (EDDOs) stirred interest from industry in how best to respond. In this article, Fran DeGrazio summarizes and comments on key clarifications and recommendations that emerged in a Drug Delivery Live! online event on the topic, which she moderated.

7. 5 Keys to Supplier/Purchasing Controls – And Product Quality 10/1/2024

   The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.

8. Preparing For The FDA QMSR: Will You Be Ready? 9/3/2024

   The new FDA Quality Management System Regulation (QMSR) becomes effective in February 2026. In this article, Fran DeGrazio discusses the implications for combination product and medical device developers as they prepare to demonstrate QMSR compliance.

9. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

   The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

10. Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing 7/29/2024

    In Part 2 of a two-part series, Fran DeGrazio explains why best practices in particle testing and related risk-based approaches to product quality should not wait for official regulatory guidances and standards to catch up.