Injectable Drug Delivery Resources

  1. Using 505(B)(2) To Streamline Approval Of Combination Products 2/2/2023

    In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

  2. Your Approach To USP <382> For Your Drug Product Packaging

    The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.

  3. Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics 5/16/2025

    All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

  4. Enhancing Patient Adherence Through Autoinjector Access

    As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.

  5. Overcoming Challenges In Cell And Gene Therapy Containment

    Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

  6. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

    Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

  7. Computational Modeling Of Injection-Related Tissue Responses 6/15/2022

    Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

  8. A Step Change In Pharmaceutical Glass Packaging Innovation

    Valor Glass represents a significant, and much needed, step forward for glass innovation. Review the findings and learn how an aluminosilicate formulation can lower your glass vials' extractables profile.

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    The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery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

  10. Mitigating Particulate Risk In Injectables

    What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?