FDA Sharpens Its Pencil and Oversight Tools on Global Clinical Trial Data

In its latest FDA Voices blog post, the U.S. Food and Drug Administration (FDA) signaled heightened scrutiny of foreign clinical trial data, foreign clinical inspections, and human subject protections with the promise of greater transparency of agency findings. The FDA is using its available toolbox as the rising trend of foreign clinical work and the growing interest of foreign countries in supporting that work show no signs of slowing or reversing anytime soon. The FDA’s blog statement also comes at a time when many US sponsors are assessing their China-based clinical and manufacturing relationships in response to the BIOSECURE Act and the recent Section 1260H designation issued to WuXi AppTec, pushing companies to rethink not just who they contract with in China but how and whether that data will be defensible at the FDA. In the following list, we share some takeaways for industry, both drug and device development companies, as they take stock of their current and planned global clinical product development programs:

• Good clinical practice remains the gold standard: The FDA’s blog post doubles down on good clinical practice (GCP) as the gold standard in its review and acceptance of foreign clinical data and promises to give medical reviewers additional training to spot GCP deficiencies and data integrity concerns. For drugs, the FDA’s regulation in Part 312 has long established the criteria by which the FDA will judge acceptance of foreign data: “review and approval […] by an independent ethics committee (IEC) before initiating a study, continuing review of an ongoing study by an IEC, […] obtaining and documenting the freely given informed consent of the subject,” and FDA validation of trial data “through an onsite inspection if the agency deems it necessary.” The drug regulations additionally require extensive supporting information evidencing the GCP compliance of a foreign trial and the FDA retains broad authority to not accept nonconforming data. The FDA recommends sponsors actively engage with it at the pre-submission stage whenever they plan to use clinical data developed outside of its active oversight. Although these standards and recommendations are long-standing, the FDA’s blog post (co-authored by leaders of its drug, biologics, and device centers) sends a clear signal that the agency is sharpening its focus on how sponsors meet these expectations.
• FDA to increase foreign inspections: Despite geopolitical questions around jurisdictional selection for clinical development, the continued pressures of speed, cost, and access to subjects have kept industry looking abroad for early-stage clinical development in particular. And the FDA has been growing its global presence. Its China office in Beijing has been open since 2008, giving industry some comfort that GCP inspection of trials or data in China remains possible if necessary. The FDA likewise maintains offices in Australia, Canada, Japan, New Zealand, and other countries where clinical development frequently occurs. The FDA’s review file in its April 2025 Biologics License Application (BLA) approval for penpulimab-kcqx evidences foreign inspections in action with bioresearch monitoring (BIMO) inspections for investigators in China, including three such investigator inspections for a Phase 2 trial conducted exclusively in China in support of the BLA. Although the FDA’s blog post is careful to state that “it is not a geopolitical statement about any particular country’s scientific capacity” (and it does not mention China), the discussion of inspection access highlights a continued point of concern with sites outside the US. In its goal of maintaining “an even playing field for all [trial] sites,” the FDA’s blog post promises increased BIMO inspections including for Phase 1 foreign trials and the refinement of risk-based criteria for selecting sites to inspect, and it cautions industry that foreign clinical work will not lower the probability of BIMO inspections. However, the FDA does seem to caution that delays can occur in gaining access for inspections, potentially placing investigational new drug (IND) and marketing applications at risk of delay at sites where it cannot gain inspection access. The FDA emphasizes that sponsors should consider access for GCP site and data inspection “as a material factor in their regulatory strategy.” China, despite the FDA’s longtime presence, is a particularly acute example of the inspection access risk: The geopolitical friction that has driven the BIOSECURE Act and heightened public company disclosure expectations around China-based biotech relationships is precisely the kind of condition that could complicate inspection access. For example, many sponsors are asking whether China will impose similar reverse restrictions on work with US sponsors or even restrictions on the FDA’s ability to inspect Chinese sites.
• Inspection outcome and site access transparency to increase: While the FDA’s Inspections compliance dashboard currently publishes classification outcomes for BIMO inspections, few details are available for those inspections that do not result in a warning letter unless those details can be found in a marketing application review file. However, the FDA’s dashboard allows posting of redacted Form FDA 483 inspection observations that the agency issues, and the FDA may be signaling that it will begin regularly posting BIMO inspection 483s moving forward. The FDA notes that it will also be giving greater transparency when sites, personnel, and documents are unavailable for inspection or when access is “conditioned on agreements the FDA cannot execute” (e.g., “attest[ing] to geopolitical principles unrelated to” inspections). The FDA encourages sponsors to factor these access issues into their site-selection decision-making.

For biotech and medtech developers, this is more than a reminder to “follow GCP.” It is a warning to build regulatory durability into their development programs from the outset. Clinical site selection (including — especially for companies with any China-related research footprint — undertaking additional diligence measures to assess potential BIOSECURE-related risks), investigator and trial oversight, informed-consent practices, source-data access, and the practical ability of the FDA to inspect a site should be considered alongside endpoint selection, enrollment timelines, and development costs, not after the study is underway or complete. The consequences of getting those decisions wrong can extend well beyond a compliance finding: Data may be excluded from regulatory consideration, development timelines may be disrupted, and the value of a company’s most important clinical asset may be called into question.

The FDA’s focus on accelerating clinical development in the US (including through its proposed expedited investigational new drug pilot for first-in-human research) and its proposal to give a 50% Prescription Drug User Fee Act application discount for applications including one or more Phase 1 trials anchored in the US after October 1, 2027, should be read alongside this policy statement on scrutinizing ex-US clinical data. For companies operating with limited capital and compressed timelines, the calculus is particularly important: The cheapest or fastest early clinical strategy may not necessarily be the most efficient long-term regulatory strategy. As the FDA adds resources to increase scrutiny of foreign clinical data and signals that inspectability, inspection history, and data provenance will receive greater attention, sponsors should be asking now — not at the time of submission — whether their clinical development strategy will withstand FDA scrutiny when the data matter most.

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Goodwin’s Life Sciences Regulatory & Compliance team regularly counsels biotech and medtech developers on their clinical development programs and is proud to partner with developers on their global regulatory plans.