In a significant milestone for the biopharmaceutical industry, AGC Biologics' Seattle site successfully underwent a multi-product inspection by the U.S. Food and Drug Administration (FDA) in March 2024. This comprehensive evaluation was aimed at supporting Biologics License Applications (BLA)
The article delves into the escalating scrutiny by US lawmakers on Chinese biotech and medtech companies, which they allege pose significant national security risks. These legislative actions are part of a broader strategy to curb Chinese influence and secure US technology and intellectual
The FDA's Center for Drug Evaluation and Research (CDER) has embarked on a robust modernization initiative to transform its New Drug Regulatory Program (NDRP). Launched in 2017, this comprehensive effort aims to enhance the efficiency and effectiveness of CDER processes in response to
The FDA's New Drug Regulatory Program (NDRP) within the Center for Drug Evaluation and Research (CDER) has undergone substantial modernization efforts since its launch in 2017. Aimed at enhancing the efficiency and effectiveness of CDER processes in light of advances in genetic science,
The biopharmaceutical industry is currently experiencing a profound transformation, as companies, both large and small, are compelled to reassess their workforce levels. This sweeping realignment is a result of several factors influencing the sector, including diminished funding opportunities, the
The winds of change are coursing through the corridors of the European Union (EU) institutions as sweeping reforms to pharmaceutical legislation are poised to redefine the biopharmaceutical playing field. Originating from the European Commission's Pharmaceutical Strategy for Europe, these
