Injectable Drug Delivery Resources

51. Decoding the FDA Guidance on Essential Drug Delivery Outputs 2/18/2025

    The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

52. The Importance Of A Human Centered Approach To Product Development

    To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

53. Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

    Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

54. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

55. Key Considerations For Packaging Solutions For Cell And Gene Therapies

    Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.

56. New Technologies To Improve Solubility Of Brick Dust Compounds 7/13/2022

    David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.

57. De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions 6/26/2025

    BD Physioject™ for Tirzepatide supports FDA ANDA submissions with proven usability, low error rates, and a design validated to match the reference listed autoinjector.

58. Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

    Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

59. Switching From Vials To PFS And Intravenous To Subcutaneous Formulations 7/25/2023

    Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

60. Early Decisions To De-Risk The Transition To Combination Products

    The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?