Regulatory Compliance

A significant regulatory debate has erupted over the FDA’s September 2025 draft guidance for disseminated coccidioidomycosis (Valley Fever). The conflict highlights a central tension in modern drug development: how to apply "gold standard" evidence requirements to diseases that technically fit the "rare" profile but lack the official designation.

Regulatory history was made this past month. For the first time, the U.S. Food and Drug Administration (FDA) has qualified an artificial intelligence-based tool to support drug development.

As we close out 2025, one thing is undeniably clear: The era of "best efforts" for diversity in clinical trials is over.

eConsent has become a critical component in clinical trials, offering improvements in efficiency

In an effort to enhance racial and ethnic diversity in clinical trials

In August 2023, the FDA provided a significant update to its Informed Consent