This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA. The pharmaceutical ...

This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA.

Valerie Bandy, Tecsys, discusses how manufacturers are adopting data-driven supply chain strategies to reduce drug shortages, ...

There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound ...

Learn how to anticipate development bottlenecks early to keep biologic programs on track for first-in-human trials. Hear how to leverage integrated platforms and operational alignment to manage ...

Regionalized early development affects clinical supply, analytical transfer, comparability strategies, and regulatory ...

Reports indicate White House approval to remove Marty Makary, reflecting internal discomfort with political fallout from provocative regulatory shifts and intensifying congressional and ...

FDA leadership churn and reported political interference eroded internal cohesion, contributing to resignations of senior career officials and a climate of dysfunction impacting scientific review ...

Regulatory expectations align across WHO, EU, PIC/S, and Health Canada; US 21 CFR 211.186/211.188 define MPCR content and faithful BPCR reproduction. Inspection trends highlight uncontrolled page ...

As a critical raw material for our manufacturing operations, media and buffers sit at the heart of the supply chain. On the ...

Isolator-based Grade A/ISO 5 architectures minimize operator interventions, enabling robust contamination control and compliance with EU GMP Annex 1, FDA guidance, PIC/S, and ISO 14644. Lyophilization ...