Injectable Drug Delivery Resources

  1. 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    The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs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.

  2. Overcoming A Failed Design Verification Test For Your Delivery Device 4/6/2022

    If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.

  3. Selecting An Alternative Coating Technology To Silicone Oil For Prefillable Syringes 5/5/2022

    The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

  4. Annex 1 – The Brave New World Of Regulatory Compliance 2/3/2023

    The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

  5. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

  6. Liposome Vs. Lipid Nanoparticle: What's The Difference? 8/10/2022

    Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.

  7. Delivering Market Success For Pharma Partners From Concept To Patient

    The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.

  8. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.

  9. Bag Flling Is Now Possible In The United States 2/10/2023

    Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).

  10. Fixtures And Surrogates For Combination Product Performance Testing 5/16/2025

    The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.