Navigating FDA changes: Seven actions for sponsors

Advancing your drug program

With over four decades of experience, Parexel’s roots lie in regulatory consulting. Throughout this time, we have guided our customers through complex global regulations and helped them to adapt to evolving agency structures and processes. In early 2025, this focus includes navigating changes at US FDA, while ensuring continuity in drug development. 

At Parexel, we recommend seven key actions: 

1. Prioritize timely submission of your IND application, new (or amended) protocol, and FDA meeting request

To date, scientific review staff in the drugs and biologics centers are less impacted by workforce reduction. We have not observed changes in approval durations, with the added assurance that FDA commits to timelines as part of various User Fee Acts/Agreements (UFAs) with sponsors. However, there is likely to be some near-term disruption with other restructuring and cuts across the agency, which may impact meeting schedules. Proactive preparation may prove advantageous in this environment. 

2. Begin with FDA-approved approaches

Negotiation with FDA over the acceptability of novel methods routinely takes time. By utilizing existing FDA guidance and regulatory precedent for manufacturing processes, clinical trial endpoints and other protocol components, development can maintain momentum. 

3. Continue to request FDA meetings

Particularly for innovative products or those addressing an unmet medical need, obtain documented FDA feedback and alignment to support continued development steps. Follow FDA meeting guidance for submissions and timelines, and focus on issues most important to inform future decision making. 

4. Target expedited programs

Develop strategies to efficiently obtain data for fast track, breakthrough therapy, priority review and accelerated approval. These designations indicate products with potential to address unmet medical needs for serious conditions, potentially gaining FDA priority in a resource-limited environment. 

5. Ensure first-time right data

Submit accurate data from the outset to reduce the risk of delays, additional information requests and potential compliance issues, such as Form 483 observations. Discrepancies and inconsistencies can lead to extended review times. 

6. Leverage plans for global development

With the similarities in scientific evaluation of medical products, development that aligns with guidance from the EMA, MHRA, and other ICH countries will likely be consistent with FDA expectations. Seek early or concurrent international regulatory input to effectively manage global development. 

7. Engage an experienced regulatory partner to critically evaluate your development plan  

Experts, particularly former regulators who understand precedents and FDA rationale for decisions, can serve as a proxy for the agency’s perspectives. They can carefully assess your program for regulatory opportunities and pitfalls, and answer nuanced questions such as: “What is the outlook for FDA granting accelerated approval for the studied indication using the planned surrogate endpoint?” or “What is the body of evidence that FDA would require to support RMAT designation, and is the available data adequate?”  This ensures robust, informed preparation ahead of meetings and submissions. 

Next steps

With a team of 1,300+ regulatory specialists, including former regulators from agencies across the world, Parexel has the knowledge, insights, and technology-enabled processes to accelerate and streamline your drug development journey. With experience in more than 110 countries, we provide strategic regulatory advice, proactively identify and mitigate risks and navigate the ever-evolving regulatory landscape – including managing the implications of regulatory agency changes. Please get in touch, we’re always available for a conversation. 

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