The US Food and Drug Administration’s phased roll out of its “integrated assessment” of drug and biological license applications has gained momentum as more than 30 marketing applications have gone through the new review process and another three dozen or so are currently undergoing this assessment.
US FDA’s New ‘Integrated’ Review Process Starts To Win Over Skeptics, But Industry Still Wants More Details
In an interview with the Pink Sheet, implementation director Rhonda Hearns-Stewart says FDA has modified the template for its 'integrated assessment' of marketing applications in response to feedback from reviewers and sponsors.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
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