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The U.S. Food and Drug Administration (FDA) is undergoing significant change. Recent announcements have highlighted budget constraints, hiring freezes, and reductions in force (RIFs) across federal health agencies, including the FDA. These shifts have raised important questions across the industry about the potential impact on regulatory operations and timelines.
Understandably, many sponsor organizations are asking: What does this mean for our clinical development programs?
The answer, at least for now, appears to be one of cautious stability.
While some policy and administrative areas within the FDA are being affected, the agency’s core regulatory review functions appear to be continuing without major disruption. INDs and NDAs are being reviewed on time, meetings are being granted, and communication remains consistent across many divisions.
Still, reductions in force and turnover, particularly among project managers and support staff, can introduce challenges. Consistent communication and well-coordinated submissions are more important than ever. Organizations that understand how to effectively engage with the FDA—and adjust to shifting agency dynamics—will be better positioned to keep their programs on track.
At Veristat, we’re working closely with sponsors to support strong, respectful communication with FDA teams and to tailor regulatory strategies that reflect current realities.
We’re not seeing delays at the level of drug development,” says John Kirk, ScD, Principal Regulatory Strategist at Veristat. “But it’s important to be thoughtful and proactive in how we engage with the agency during this time.”
Watch the full video update from John to hear more about what we’re seeing across the industry—and how Veristat is helping sponsors move forward with confidence.
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