FDA Rolls Out “Gold Standard Science” Playbook—What It Means for Sponsors and Scientists
In May, President Donald Trump signed the Executive Order “Restoring Gold Standard Science”—a sweeping directive telling federal agencies to anchor research and regulatory decisions in reproducibility, transparency, quantified uncertainty, skepticism, and unbiased peer review. White House+1
On August 13, FDA unveiled a 21-page Staff Manual Guide (SMG) 9001, “Gold Standard Science at FDA,” describing how every Center will implement the order and how employees should operationalize it in daily work—from record-keeping and peer review to dispute resolution and communication standards. The SMG took effect August 15, 2025. U.S. Food and Drug Administration+1
What’s inside the guide
Applies agency-wide. SMG 9001 covers all FDA Centers, Offices, and Programs (CDER, CBER, CDRH, CVM, CTP, HFP, NCTR, OCE, ORA, and the Office of the Commissioner), setting common expectations for research the agency conducts, funds, or relies on in decisions. U.S. Food and Drug Administration
Nine core tenets. FDA explicitly aligns to the EO’s pillars: reproducible, transparent, communicative of error and uncertainty, collaborative, skeptical of findings, falsifiable, subject to unbiased peer review, accepting of negative results, and free of conflicts of interest. U.S. Food and Drug Administration
How to communicate uncertainty (the must-read section).
SMG 9001 instructs staff to include quantitative measures (e.g., confidence intervals, error margins, sensitivity analyses) and to be precise about what findings do—and do not—establish. Crucially:
“To prevent overstatement of results, FDA communications should be presented in cautious, evidence-based language … [and] avoid speculative claims or extrapolations that extend beyond the data’s scope.” U.S. Food and Drug Administration
Process for raising concerns. FDA’s Office of Scientific Integrity is the front door for “Gold Standard Science” issues and adjudication, with protections against retaliation and a panel process that can escalate concerns to the Commissioner. U.S. Food and Drug Administration
Operationalization and training. Each Center must write or update internal procedures, train staff, and ensure consistent implementation, tying the SMG to the broader HHS “Gold Standard Science” program. U.S. Food and Drug Administration+2Health and Human Services+2
What’s new—and what’s not
Much of SMG 9001 formalizes long-standing FDA norms (peer review, record integrity, conflict management, scientific dispute resolution). What’s new is the agency-level codification of the EO’s nine tenets, a centralized process for reporting GSS-related concerns, and explicit, quotable standards for how FDA communicates uncertainty to the public—elements likely to shape reviews, press statements, advisory committee briefing books, and postmarket safety communications. U.S. Food and Drug Administration
Why sponsors and investigators should care
Briefing materials & labeling: Expect tighter expectations for quantifying uncertainty and avoiding over-interpretation in briefing docs, labeling justifications, and public summaries. Build those statistical guardrails in early. U.S. Food and Drug Administration
Study design rigor: The emphasis on falsifiability and replication strengthens FDA’s hand in challenging fragile endpoints or under-powered analyses—especially for confirmatory evidence in accelerated approvals. U.S. Food and Drug Administration
Dispute playbook: Scientific disagreements may increasingly route through OSI processes; document alternative analyses and maintain pristine records to support your position. U.S. Food and Drug Administration
Public communications: Manufacturer communications that mirror FDA’s “cautious, evidence-based” tone will land better with reviewers and the press; over-confident narratives could face skepticism. U.S. Food and Drug Administration
The policy context
HHS and other agencies have posted their own “Gold Standard Science” implementation plans, aligning timelines and expectations across the government. Whatever your view of the EO’s politics, the operational bar at FDA is now written down in one place—and it cites the EO by number (Executive Order 14303). Plan your submissions and communications accordingly. Health and Human Services+1
Bottom line
FDA’s Gold Standard Science manual doesn’t revolutionize the agency’s scientific culture; it codifies and sharpens it. For sponsors, the practical takeaway is simple: quantify uncertainty, avoid speculative claims, document rigor, and be prepared to defend methods and interpretations. Doing so won’t just meet a new policy—it’ll make your science stronger. U.S. Food and Drug Administration
