What specific regulatory improvement did BIO CEO John Crowley call for to address uncertainty in drug reviews, especially for rare diseases?

BIO CEO John Crowley called for greater consistency in the FDA's drug review process, specifically advocating for standardized review criteria that currently vary widely across disease categories and molecule types, noting that 'there is uncertainty in the regulatory review process for many medicines, especially in rare diseases' and emphasizing the need for clearer standards to determine eligibility for special review designations like breakthrough therapy.

According to John Crowley, why is standardizing FDA drug review criteria considered urgent, and how does it relate to broader national priorities?

Crowley framed standardizing FDA drug review criteria as the 'next big need' after collaborative efforts to speed clinical trials, linking it directly to national competitiveness amid 'the growing competitive threat from China and artificial intelligence'; he stressed that biotechnology is 'a national strategic asset' and that alignment with Congress and the administration on these issues is bipartisan.

BIO CEO Calls for Greater Consistency in FDA Drug Review Process

Jun 23, 2026

BIO CEO John Crowley urges the FDA to standardize drug application reviews to reduce uncertainty, particularly for rare diseases, as part of broader efforts to accelerate clinical trials and maintain U.S. leadership.

reuters

2026-06-23

BIO CEO Calls for Greater Consistency in FDA Drug Review Process

BIO CEO Calls for Greater Consistency in FDA Drug Review Process

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