FDA (CDER)
GUIDANCE FINAL
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry
Published: 12/15/2025Detected: 3/19/2026
Summary preview
Enhances FDA expectations for designing and conducting clinical trials to improve participant access and representativeness while maintaining rigorous eligibility, enrollment, and trial design standards.
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safety
labeling
manufacturing
quality
#clinical trials
#eligibility criteria
#enrollment practices
#trial design
#recruitment
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