Featured Articles

  1. 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.

  2. De-Risking Visible Particles Through Component Selection

    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

  3. A Proactive Approach To Reducing Particulate Risk

    A biotech that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines.

  4. Functional Performance Of Stoppers To Support Multipuncture Use

    Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

  5. Design Success Combined With Expertise In Testing And Raw Material Selection

    Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

  6. FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III

    The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.

  7. Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers

    Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.

  8. 4031 Ready Methods Reduce E&L Timelines

    An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

  9. 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.

  10. 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.