What forces are shaping today’s regulatory environment? In this latest Q&A, we asked our Former FDA Expert Team to weigh in on some of the most pressing questions facing the Agency and the industries it oversees, from balancing innovation and safety to navigating new technologies like AI and real-world evidence. Their candid insights reveal how cultural shifts, policy changes, and scientific advances are reshaping the FDA’s role and the practical realities for companies operating under its oversight.
Here are their thoughts on some of the most significant issues affecting the Agency today.
Q: What do you see as the FDA’s single most significant challenge in balancing innovation and safety across the entire life sciences industry?
Former FDA Expert Team: Balancing innovation and safety has always been one of the FDA’s most complex and enduring challenges, a tension between the pace of scientific advancement and the deliberate caution required to protect public health. Innovation inherently moves fast, while safety demands careful, methodical evaluation. Finding equilibrium between these forces is not a static goal but a continual process of adaptation.
One of the Agency’s greatest hurdles today lies in keeping regulatory frameworks aligned with the speed and complexity of emerging technologies, particularly in areas like artificial intelligence, digital health, advanced manufacturing, oncology, and gene therapy. These fields evolve far faster than traditional regulatory systems were designed to accommodate. As a result, the FDA must continually develop new benefit–risk assessment tools and policy frameworks to ensure that innovative therapies reach patients without compromising safety.
At the same time, the Agency faces significant internal challenges. Recent reductions in staff and the loss of experienced investigators and managers have strained the FDA’s capacity to maintain consistent oversight. A well-trained and adequately resourced field staff, particularly within the Office of Inspections and Investigations, is essential for evaluating the safety and quality of products across all commodity areas, from food to biologics.
Ultimately, the FDA’s ability to balance innovation and safety depends on its agility: adapting regulatory science and infrastructure at the same pace as the technologies it oversees, while ensuring its workforce remains prepared, supported, and equipped to apply that science in practice.
Q: How has public trust in FDA decisions changed in recent years, and what does that mean for the companies regulated by the Agency?
Former FDA Expert Team: Public trust in the FDA’s work has become one of the most complex and consequential challenges facing the Agency today. While the FDA continues to uphold its mission of protecting public health through science-based regulation, public confidence in that work has eroded in recent years. This decline stems from multiple factors: political polarization, misinformation, and the intense scrutiny of FDA decisions during crises such as the COVID-19 pandemic.
The pandemic became a flashpoint for misunderstanding the Agency’s processes. Emergency Use Authorizations (EUAs), intended as critical tools to accelerate access to vaccines and therapies, were often misconstrued as shortcuts or compromises in safety. Products like the Novavax vaccine highlighted the public’s limited awareness of the difference between EUA and full licensure, creating confusion that further fueled skepticism. Similarly, events such as the infant formula shortages reinforced concerns about regulatory oversight and consistency.
From our perspective, public trust has also become more volatile; decisions once viewed as strictly scientific are now filtered through political and media narratives. Even evidence-based actions can be perceived as biased or inconsistent, complicating the FDA’s ability to communicate nuanced risk–benefit decisions.
For companies, this shifting environment means that compliance alone is no longer enough. Firms must proactively communicate their values of safety, quality, and efficacy, and invest in transparent, patient-centered outreach to bridge the gap between scientific decision-making and public perception.
Looking ahead, the direction of new administrative priorities, including potential efforts to streamline regulation, remains uncertain. Regardless of policy changes, the public continues to expect that the FDA will safeguard health with integrity and transparency. Restoring trust will require not only sound science within the Agency, but also open engagement across industry and the broader public health community.
Q: Is the pace of industry innovation outstripping the FDA’s infrastructure, and if so, where do you see the gap showing up most clearly?
Former FDA Expert Team: There is indeed a growing gap between the life sciences industry’s ability to generate complex data and the FDA’s capacity to process and interpret it thoroughly. The speed and sophistication of today’s data, especially from AI-driven analyses, adaptive trials, and real-world evidence, have outpaced systems that were initially built for more traditional submissions.
From our experience managing regulatory IT infrastructure, the Agency’s internal systems are still adapting to handle this influx. While the FDA has begun implementing advanced analytic platforms, these tools are not yet “smart” enough to synthesize the highly variable and nuanced data now arriving. It will take time and validation before both the tools and their users — reviewers and analysts alike — can fully trust the outputs.
The challenge is not only technological but also human. Many field investigators and reviewers are still gaining experience with new and emerging technologies. For instance, as the number of firms developing cell and gene therapies expands (potentially reaching over a thousand in the coming decade), the need for specialized training and technical expertise will grow even more urgent.
Q: Looking ahead, what type of product or technology will most force the FDA to rethink its traditional playbook?
Former FDA Expert Team: Several emerging areas are poised to challenge the FDA’s traditional playbook. Patient-generated data will increasingly shape medical product development, forcing the Agency to reconsider how real-world information is validated and incorporated into regulatory decisions.
Artificial intelligence continues to be a significant disruptor; from clinical trial design to diagnostic support, it demands new approaches to transparency, validation, and lifecycle oversight.
We also expect tension around products that blur the line between regulated medical devices and general wellness technologies, where questions of intended use, risk classification, and marketing claims will test the boundaries of current policy.
Finally, the rapid expansion of cell and gene therapies may drive the most significant structural change. The projected growth of this sector will likely require a specialized review and inspection framework, potentially even a dedicated Center within the FDA, to manage its scale and complexity.
Q: If you had to name one cultural trait inside the FDA that most shapes its decisions, but is least understood by outsiders, what would it be?
Former FDA Expert Team: Inside the FDA, there is a deeply ingrained culture of public service and responsibility that often goes unseen from the outside. Employees across the Agency, whether in review divisions or inspection offices, take their duty to protect public health extremely seriously. This shared sense of accountability shapes every decision.
That commitment also fosters a culture of caution. Reviews are intentionally thorough, sometimes involving multiple layers of redundancy, and the Agency tends to err on the side of risk aversion when uncertainties remain. While this can lengthen approval timelines, it reflects the FDA’s mandate to ensure that products entering the market are both safe and effective.
Another aspect often misunderstood is the degree of coordination required among multiple offices and centers. Decisions are not made in isolation; review centers like CBER work closely with a field inspectorate like the Office of Biological Inspectorate to verify that manufacturing facilities meet standards. Many approvals hinge as much on site readiness as on the science itself, underscoring the FDA’s holistic approach to product safety and efficacy.
Q: If you could change one thing about FDA submissions tomorrow, what would it be and why would it help?
Former FDA Expert Team: If we could change one thing about FDA submissions, it would be to better equip and support the reviewers who make the process work. Reviewers carry heavy workloads, often without the time or technological resources needed to stay current with evolving science and tools. Expanding reviewer capacity would not only help distribute that workload more evenly but also allow time for training and exploration of new methodologies.
Modernizing the technology that supports the review process is equally important. Many of the systems in use are outdated or cumbersome, slowing down the Total Product Life Cycle (TPLC) review and limiting efficiency.
We’d also like to see greater emphasis on the CMC (Chemistry, Manufacturing, and Controls) sections of biological drug submissions, particularly around Critical Quality Attributes and Critical Process Parameters, paired with more pre-submission meetings. Early, substantive dialogue between sponsors and the Agency could streamline the path to approval and strengthen the quality of submissions overall.
Q: What minor tweak has an outsized impact on submission quality or speed?
Former FDA Expert Team: One of the most impactful but often overlooked factors in submission quality and speed is reviewer continuity. High turnover within review divisions can slow the process considerably, as new staff must be hired, trained, and brought up to speed, often leading to a loss of institutional knowledge that affects consistency and efficiency.
Beyond staffing, early and open communication between sponsors and the Agency remains one of the simplest ways to improve outcomes. More frequent pre-submission meetings allow potential issues to be addressed upfront, resulting in clearer, stronger submissions and faster, more predictable reviews.
Q: What is the most misunderstood FDA document: a 483, a Warning Letter, or an Untitled Letter? What do people wrongly think it proves?
Former FDA Expert Team: The FDA Form 483 is probably the most misunderstood of the three. Many people assume it represents a final Agency determination about a facility’s compliance status, when in reality it’s only a snapshot in time: the investigator’s observations during a specific inspection.
A 483 is not exhaustive, nor does its absence imply perfection. Investigators typically have just a few days on site and can only assess a limited portion of operations. The document identifies potential issues observed during that inspection; the final classification and any regulatory action are determined later by the appropriate FDA center after a broader review.
Q: When comparing a Remote Regulatory Assessment to a traditional on-site inspection, what is the single most important distinction that outsiders often overlook?
Former FDA Expert Team: The key distinction between a Remote Regulatory Assessment (RRA) and a traditional on-site inspection is often misunderstood. While RRAs are sometimes perceived as less demanding, they can be just as time-intensive in the early stages when companies are gathering documents and granting access for remote review.
However, an RRA is not a complete substitute for an on-site inspection. Remote assessments allow for thorough data review, but they lack the in-person context that comes from speaking directly with plant personnel — operators, scientists, and quality staff — whose insights often reveal critical details about a facility’s operations. In short, RRAs are valuable tools, but the on-site inspection remains the gold standard for understanding a firm’s actual state of compliance.
Q: What is the one must-have that makes real-world evidence (RWE) decision-grade, and what is the deal breaker that renders it unusable?
Former FDA Expert Team: For real-world evidence (RWE) to be decision-grade, the underlying real-world data (RWD) must be high quality and fit for its intended purpose. That means data sources are reliable, well-characterized, and capable of answering the specific regulatory question being asked.
Equally important is having a prespecified study design established before data collection begins. Without it, analyses risk appearing biased, selective, or “cherry-picked.”
The deal breaker is poor data integrity or methodology misaligned with the regulatory objective. If the data set isn’t robust, relevant, and collected under a clearly defined protocol, it won’t meet the evidentiary standard needed to inform FDA decision-making.
Q: Within FDA inspections, what priority has quietly moved up or down the ladder over the last few years?
Former FDA Expert Team: In recent years, inspection priorities within the FDA have shifted in subtle but important ways. For the Center for Devices and Radiological Health (CDRH), Good Laboratory Practice (GLP) inspections — particularly outside the United States — have gained prominence as the Agency increases its global oversight efforts.
At the same time, the overall inspection model has become increasingly risk-based. With limited field resources and a growing inventory of regulated firms, the FDA has had to prioritize inspections based on risk categorizations rather than routine coverage. Comprehensive inspections that once reviewed all six quality systems now often focus on four or even two, depending on scope and risk level.
While this “do more with less” approach allows broader coverage, it has also meant that some aspects of quality oversight have moved down the ladder in practice. The emphasis on efficiency and numerical targets can sometimes dilute the depth of quality evaluations, a tradeoff the Agency continues to balance as it refines its inspection strategy.
Q: As FDA staffing and capacity evolve, what is one change companies will tangibly feel in 2025-2026, and what practical workaround can companies use to adapt?
Former FDA Expert Team: In 2025 and into 2026, companies are likely to feel the impact of the FDA’s staffing shortages and leadership transitions in very tangible ways. A reduced and reorganized workforce will slow the pace of regulatory interactions, from premarket reviews to routine inspections. Firms may find it takes longer to receive feedback, schedule meetings, or obtain clarifications on submissions.
With fewer staff available for one-on-one engagement, the Agency may rely more on trade associations or collective industry forums to address common questions efficiently, rather than meeting with individual companies. This shift will require patience, professionalism, and strategic communication from firms seeking feedback.
In the meantime, companies should make full use of existing channels like the Q-Submission (Q-Sub) process, established Points of Contact within the Centers, and electronic correspondence to keep communication flowing. For compliance oversight, it’s also wise to engage qualified consultants who can perform internal assessments and help maintain readiness, especially when on-site FDA visits become less frequent.
Q: In your view, what is the single biggest operational or cultural challenge facing your former Center over the next five years, and how will the industry most directly feel the effects?
Former FDA Expert Team: Over the next five years, one of the biggest challenges facing the Centers will be maintaining institutional knowledge and technical expertise amid leadership turnover and staffing reductions. The departure of senior leaders and experienced reviewers, whether through retirement, restructuring, or moves to industry, will inevitably create gaps that affect consistency, institutional memory, and the overall pace of review.
This transition will be felt most directly through slower or less predictable regulatory interactions. As new reviewers come on board and learn complex policies, companies may experience more iterative information requests and subtle shifts in expectations compared to past submissions.
Recruiting and retaining reviewers with the skills to evaluate rapidly advancing technologies — such as mRNA platforms, cell and gene therapies, and AI-enabled devices — remains a major operational hurdle. The Agency is also beginning to incorporate AI and digital tools, like digital twins, into its own review processes. While guidance around these technologies is evolving, the FDA’s ability to keep pace with industry innovation will take time.
For industry, the result may be both uncertainty and adjustment: longer review cycles, evolving interpretations, and challenges aligning investments with regulatory clarity. The loss of experienced leadership won’t just affect the FDA internally — it will ripple outward, influencing how efficiently innovation reaches patients.
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