FDA Science Forum 2027
U.S. Food & Drug Administration — White Oak Campus, Silver Spring MD
About the FDA Science Forum
The FDA Science Forum is an annual two-day symposium organised by the U.S. Food and Drug Administration that brings together FDA scientists, academic researchers, and external experts to discuss advances in regulatory science — the scientific foundation underpinning every FDA regulatory decision.
Topics span the full regulatory lifecycle: pre-IND scientific advice, biomarker qualification, clinical trial design innovations, pharmacometric modelling, real-world evidence, pharmacovigilance, and post-market safety surveillance. The forum provides a rare window into how FDA uses science to make regulatory decisions and where it is investing research resources.
The FDA's Advancing Regulatory Science initiative provides the overarching framework for these research priorities. Key FDA offices presenting at the forum include the Office of Clinical Pharmacology (OCP), the Oncology Center of Excellence, and the Office of Biostatistics.
Key Scientific Tracks
Machine learning models for toxicity prediction, AI-assisted clinical trial design, natural language processing for adverse event signal detection in FAERS, and generative AI in regulatory submissions.
Population PK/PD modelling for label dose recommendations, model-informed drug development (MIDD), PBPK analyses for DDI predictions, and paediatric extrapolation using PK modelling.
FDA's RWE programme for regulatory decision-making, Sentinel System active surveillance methods, and external control arm studies for rare diseases.
Biomarker qualification via the FDA Biomarker Qualification Program, patient-reported outcomes (PROs) as trial endpoints, digital biomarkers from wearables, and circulating tumour DNA (ctDNA) in oncology trials.
Signal detection methods in FAERS and Sentinel, disproportionality analysis, vaccine safety monitoring via the Vaccine Adverse Event Reporting System (VAERS), and REMS programme effectiveness evaluation.
Rare Paediatric Disease priority review vouchers, natural history studies, Accelerated Approval pathway reforms, and external control arms using patient registries.
What is Regulatory Science?
Regulatory science is the discipline of developing and applying scientific methods, tools, and standards to evaluate the safety, efficacy, quality, and performance of regulated products. Unlike bench science that aims to understand disease, regulatory science aims to answer the question: "Is this product safe and effective enough to approve?"
Key regulatory science areas relevant to pharmacists and clinical pharmacologists include:
FAQ
What is the FDA Science Forum?
An annual two-day FDA symposium showcasing regulatory science advances across drug review, pharmacometrics, AI/ML, real-world evidence, pharmacovigilance, and rare disease development. Open to FDA staff and external participants.
Who can attend?
FDA staff and external participants including academic researchers, pharmaceutical industry scientists, regulators, and healthcare professionals. Registration is required; virtual attendance is typically free.
Is it free to attend?
The FDA Science Forum is typically free or low-cost for external attendees. Virtual attendance is generally free. Check the FDA Science Forum page for 2027 registration details.
What is regulatory science?
Regulatory science develops tools, standards, and methods to assess whether products are safe and effective. For drugs, this includes PK/PD modelling, biomarker qualification, adaptive trial design, and pharmacovigilance methodology.