Cell and gene therapies continue to transform the treatment landscape, and in 2026, both the FDA and the European Union will have updated frameworks that reshape how these advanced therapies are developed, approved, and monitored. Companies working in this space must prepare for evolving expectations around safety, manufacturing, and long term follow up.

The FDA’s approach to drug approvals is evolving, and in 2026, pharmaceutical and biotech companies will need to adapt to new expectations for confirmatory trials and the use of real world evidence.

The European Union is moving forward with the largest reform of its pharmaceutical legislation in more than two decades.

In vitro diagnostic manufacturers are approaching an important milestone under the European Union’s In Vitro Diagnostic Regulation (IVDR).

Cybersecurity has become a top regulatory priority as medical devices become more connected and software driven.

Artificial intelligence is transforming medical devices and digital health technology, and regulators in both the United States and Europe are preparing new oversight frameworks that will take effect by 2026.

After years of development, the EU’s comprehensive medical device database (EUDAMED) becomes mandatory in phases starting in early 2026.

Medical devices are only as safe and effective as their users’ ability to operate them correctly. Even the most advanced technology can fail if patients or healthcare professionals misunderstand instructions, misuse the device, or encounter confusing interfaces. Regulators now recognize usability and human factors as central to patient safety. In 2025, both FDA and EU regulators are emphasizing patient-centric design, usability validation, and clear labeling. These expectatio

European medical device makers face a key May 26, 2026 deadline under the extended MDR transition timelines.