Regulatory

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

The Inflation Reduction Act (IRA) marks a significant milestone in U.S. healthcare reform, particularly for those covered by Medicare. This comprehensive legislation introduces an array of policy changes poised to transform numerous sectors within the healthcare industry. One of the most crucial

The biopharmaceutical industry is currently navigating through turbulent waters as a series of layoffs and strategic overhauls ripple across the sector. The urgency that once underscored the COVID-19 pandemic has given way to a new reality where pharmaceutical giants are reassessing their