Featured Pharma Online Editorial

1. Will FDA Finally Enforce DSCSA Interoperability In 2025? 12/26/2024

   Two experts weigh in on the persistent problems surrounding the Drug Supply Chain Security Act and its upcoming enforcement deadlines.

2. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

3. 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.

4. 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?

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.