Researchers urge FDA to adopt EMA-style drug rejection letter disclosures

The FDA began publishing letters that explain why a drug application was denied in September 2025, marking a significant transparency shift.

Researchers argue that the agency’s current disclosures are still developing and could be improved by following the European Medicines Agency’s more detailed approach.

They suggest that adopting EMA’s format would give clinicians, investors, and the public clearer insight into the reasons behind rejections, potentially enhancing trust in the regulatory process.

The call comes as the FDA continues to refine its policy, indicating that future releases may become more comprehensive.