Featured Pharma Online Editorial

  1. The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond 12/2/2024

    These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

  2. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

    The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

  3. 3 Focus Areas To Transition From Clinical To Commercial Readiness 11/12/2024

    Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.

  4. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

  5. What's Next After FDA's DSCSA Extension? 10/18/2024

    Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

  6. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

    Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

  7. Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain 9/25/2024

    Generic drug manufacturers must carefully consider the decision to offshore or nearshore API sourcing. It's not only about managing costs but also about ensuring a stable and reliable supply.

  8. Should You Be Using Unique Container Identification? 8/22/2024

    Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

  9. DSCSA Implementation Is Progressing, But More Complexity May Be Coming 8/5/2024

    The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.

  10. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.