Key Takeaways from the CDRH 2025 Annual Report

The 2025 CDRH Annual Report provides a comprehensive overview of the Center’s continued progress in balancing the review of new medical technologies with the rigorous oversight of patient safety. This latest update shows the FDA meeting its commitment to predictable regulatory pathways, ensuring that both manufacturers and patients can rely on consistent standards of excellence. … Read more

How the FDA’s Assessment Aid is Revolutionizing Oncology Reviews

In the fast-paced world of oncology, every second counts for patients awaiting life-saving treatments. The FDA’s Assessment Aid is a game-changing tool designed to strip away administrative red tape and put the focus back on what matters most: critical scientific evaluation. By streamlining the communications between drug developers and regulators, this initiative is redefining the … Read more