Featured Editorial

31. 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.

32. 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.

33. 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.

34. 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    The FDA draft guidance on Essential Drug Delivery Outputs (EDDOs) stirred interest from industry in how best to respond.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.

35. Peptide Synthesis: New Market Research 11/3/2024

    Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research.

36. A New Approach To ISO 14971 For Better Medical Device Risk Analysis 10/23/2024

    This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

37. 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.

38. Improving Medical Device Testing With Robotic Automation 9/25/2024

    Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.

39. Araris Doubles Down With Dual-payload ADC 9/24/2024

    Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.

40. Are You Compliant? States Are Issuing New Regulations For IV Therapy Compounding 9/13/2024

    The regulatory environment surrounding IV therapy and med spas has become fragmented. In some states, the definition of compounding has been expanded.