Injectable Drug Delivery Articles

41. Trans-Arterial Micro-Perfusion For Improved Drug Delivery 6/19/2024

    Trans-arterial micro-perfusion (TAMP) is a novel approach designed to use pressure to deliver therapeutic agents directly to tumor sites.

42. The Key to Regulatory Innovation? Global Harmonization 6/4/2024

    Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices. 

43. Balancing Sustainability With Patient Safety In Medical Device Design 6/3/2024

    There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.

44. Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024

    The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

45. A Holistic Approach To Container Closure Integrity 5/20/2024

    Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

46. 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.

47. 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.

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    The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

49. 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.

50. 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.