Artificial intelligence (AI) is revolutionizing industries worldwide, and the life sciences sector is no exception. For quality and regulatory...
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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,...
As healthcare technology continues to evolve, medical devices are increasingly connected to networks, patients, and other devices, making them...
In 2024, the FDA remains focused on ensuring that medical device companies adhere to stringent regulatory requirements to guarantee patient safety...
