FRANKLY FRAN

• Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective

  5/1/2025

  In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.

• Design Controls For Drug Delivery Devices, Part 1: A Process Primer

  4/1/2025

  In this article, Fran DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls. 

• Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges

  3/4/2025

  In this article, Fran DeGrazio comments on the potential for subcutaneous delivery of drugs and biologics to advance and ease approaches to patient self-administration. Among the drivers and challenges she identifies are geriatric populations, chronic conditions, complex formulations, and drug delivery device selection.

• Use-Related Risk Analysis: Considering The FDA Guidance On URRA

  2/5/2025

  The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA. 

• Drug Delivery Outlook: 7 Waves To Ride In 2025 And Beyond

  12/30/2024

  With a view of the evolving landscape of health policy and patient needs, Fran DeGrazio identifies seven biopharmaceutical industry trends that should drive innovation and practical implementation in drug delivery. Harmonization, digitization, quality, intelligence, and agility are among the focus areas Fran recommends for forward-thinking biopharmaceutical companies. 

• 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.

• 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.

• 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.

• 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.

• 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.