The Next Episode | What 13 Years of DSCSA Teach Us About NDC-12 and Pharmaceutical Interoperability
The Transactions Haven’t Changed. The Network Has. Flying home from the HDA Traceability Seminar last week, I saw some news from Philadelphia that put much of what we had spent the previous few days discussing […]
Strengthening Patient Safety Through Practical Supplier Quality Oversight | Insights from an Rx‑360 Supplier Quality Working Group Informal Survey
Ensuring patient safety depends on the integrity of global pharmaceutical supply chains—yet Supplier Quality professionals continue to face practical, structural challenges in how audits are conducted, documented, and leveraged for assurance. To better understand current practices, Rx‑360 […]
The BIOSECURE Act and the Quiet Work Ahead for Pharmaceutical Supply Chains
The BIOSECURE Act did not arrive with ceremony. It arrived embedded in the National Defense Authorization Act, debated largely in abstractions, and passed with little public attention. But for pharmaceutical and biotechnology companies operating global […]
China’s Regulatory Reform Signals a New Era for Pharmaceutical Innovation
In a significant move to reshape its pharmaceutical landscape, China has unveiled a comprehensive guideline aimed at deepening the reform of drug and medical device regulation. Issued by the General Office of the State Council […]
Direct-to-Patient Pharmaceutical Programs
The pharmaceutical landscape is evolving rapidly, and one of the most transformative shifts is the rise of direct-to-patient (D2P) distribution. As manufacturers seek to bypass traditional channels and deliver medications straight to patients’ doors, the […]
The Life of an Rx-360 Auditor by Kristen Hedrick
Clarifying QMS Relevancy: Why We Need Industry Guidance Now
In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for […]