The U.S. Food and Drug Administration (FDA) continues to influence global clinical research through updated guidances, new accepted endpoints, and evolving regulatory expectations. For sponsors and research partners operating internationally, staying aligned with the latest FDA directions is essential for designing high-quality, inspection-ready studies.
At Tigermed EMEA — part of the Tigermed Group, a leading global CRO — we monitor these developments closely to support sponsors with compliant, accelerated, and patient-centered clinical strategies.
FDA now officially recognizes reduction in WHO-based drinking risk levels as a valid primary endpoint in clinical trials for Alcohol Use Disorder.
Trials no longer need to focus solely on complete abstinence.
Sponsors can design studies that reflect more realistic, patient-centered outcomes.
Recruitment may become easier and more representative.
How Tigermed EMEA supports:
We help optimize endpoints, define measurement tools, develop protocol language aligned with FDA expectations, and ensure robust data quality for behavioral and addiction-related studies.
The new PFDD guidance reinforces that clinical trials must capture what matters most to patients — symptom burden, quality of life, daily functioning, and treatment tolerability.
Study protocols must justify the relevance of each patient-reported outcome (PRO).
Stakeholder input (patients, caregivers, clinicians) becomes part of the evidence package.
Increased expectations for transparency and patient-centric data.
How Tigermed EMEA supports:
Our teams integrate validated PRO instruments, digital patient engagement tools, and data strategies that reflect real-world impact — ensuring submissions meet both regulatory and patient expectations.
FDA continues to prioritize breakthrough treatments across multiple therapeutic areas:
Priority Review granted for Merck’s Winrevair (sotatercept) label update, based on strong Phase 3 PAH data.
New oncology approvals, including innovative HER2-targeted therapies and AML assets such as ziftomenib, highlight the continued importance of precision medicine.
High-quality Phase 2/3 data remain the strongest driver of expedited pathways.
Biomarker strategy and molecular stratification are increasingly essential.
Academic–industry collaborations are accelerating translation from discovery to approval.
How Tigermed EMEA supports:
We deliver full-service oncology programs — including biomarker-driven designs, central lab coordination, global site activation and expert regulatory pathways — enabling sponsors to meet FDA’s expectations for innovative therapies.
FDA is reinforcing its commitment to transparency and traceability in clinical research.
Shorter reporting timelines for posting study results on ClinicalTrials.gov.
Expansion of single-IRB (sIRB) requirements for multicenter studies.
Increased expectations on diversity of study populations.
Continued shift in oncology dose-selection (Project Optimus) from MTD to “optimal biologic dose.”
How Tigermed EMEA supports:
We provide full regulatory and operational oversight across EU–US trials, ensuring alignment with sIRB requirements, diversity plans, dose justification frameworks, and ClinicalTrials.gov compliance.
Adaptive and Decentralized Trial Designs (DCTs)
Digital endpoints and real-world evidence
Inclusive recruitment strategies
Clear dose-optimization rationale, especially in oncology
At Tigermed EMEA, we continue to invest in innovative operational models, digital ecosystems, and regulatory intelligence to ensure our partners stay ahead of evolving global requirements.