For medical device companies, selecting the first market for regulatory clearance is a pivotal decision. The U.S. and European Union (EU) markets...
In medical device manufacturing, a robust Risk Management Plan (RMP) is essential to ensure the safety and efficacy of devices across their...
Artificial intelligence (AI) is revolutionizing industries worldwide, and the life sciences sector is no exception. For quality and regulatory...
The appointment of Robert F. Kennedy Jr. (RFK Jr.) to a significant role in U.S. health policy could result in a major shift in regulatory and...
Pharmaceutical and biotech companies face a dynamic regulatory landscape as they evaluate where to seek clearance or approval first. In the coming...
The FDA’s recent establishment of a rare disease innovation hub could open unprecedented opportunities for large pharmaceutical companies,...
As pharmaceutical and biotech companies strive to meet evolving FDA standards, they encounter rigorous inspections aimed at ensuring quality, safety,...
