SOCRA 2024 Annual Conference Program Book - Flipbook - Page 48
Agenda
FDA Initiatives
Chrissy J. Cochran, PhD
Initiatives
Director, FDA/ORA/OBIMO
Reorganization
Inspection
process
2
Real-World Data
Initiatives
Real-World Evidence | FDA
Center for Biologics Evaluation and Research &
Center for Drug Evaluation and Research RealWorld Evidence | FDA
Leveraging Real World Evidence in Regulatory
Submissions of Medical Devices | FDA
3
Real-World Data Guidance
REAL-WORLD DATA:
ASSESSING
REGISTRIES TO
SUPPORT
REGULATORY
DECISION-MAKING FOR
DRUG AND
BIOLOGICAL
PRODUCTS - FINAL
www.fda.gov
DATA STANDARDS FOR
DRUG AND
BIOLOGICAL PRODUCT
SUBMISSIONS
CONTAINING REALWORLD DATA - FINAL
REAL-WORLD
EVIDENCE:
CONSIDERATIONS
REGARDING NONINTERVENTIONAL
STUDIES - DRAFT
4
www.fda.gov
Equity in Clinical Trials
USE OF REAL-WORLD
EVIDENCE TO
SUPPORT
REGULATORY
DECISION-MAKING FOR
MEDICAL DEVICES DRAFT
5
www.fda.gov
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https://www.fda.gov/consumers/enhance-equity-initiative/
https://www.fda.gov/about-fda/oncology-center-excellence/project-equity
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improveenrollment-participants-underrepresented-populations-clinical-studies
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