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  6. Cross-cutting Topics: Oncology Regulatory Science Research
  1. Focus Areas of Regulatory Science Report

Cross-cutting Topics: Oncology Regulatory Science Research

 

Two male and three female doctors wearing scrubs posing for the camera.

Pursuant to the 21st Century Cures Act, FDA established the Oncology Center of Excellence (OCE). It leverages the combined skills of regulatory scientists and reviewers with expertise in the development of drugs, biological products, devices, and diagnostics to support an integrated approach to the clinical evaluation of medical products addressing cancer. For medical oncology products, OCE forms an interdisciplinary medical oncology review and evaluation team with representatives from the appropriate centers.

OCE oversees a robust regulatory science effort focusing on scientific research questions that arise during regulatory review of oncology products. In general, OCE emphasizes applied research that focuses on solving a specific practical problem rather than expanding general knowledge. Based on an analysis of scientific outreach activities, internal presentations, publications and technology transfer agreements, OCE identified nine scientific priority areas and one cross-cutting area of high interest for research. These are not the only areas of interest to OCE but represent topics with substantial existing activity.

OCE supports several intramural research projects, with a strong focus on conducting pooled analyses of clinical trial data. OCE supports extramural research projects through the BAA and CERSI programs and collaborates with some external partners using technology transfer agreements.

Oncology Regulatory Science Research
The Oncology Center of Excellence harnesses the combined skills of regulatory scientists and reviewers with expertise in the development of drugs, biological products, devices, and diagnostics to support an integrated approach to the clinical evaluation of medical products addressing cancer.

 

 

CROSS-CUTTING TOPICS

Minority Health and Health Equity Women’s Health Maternal Health Pediatric Health
Oncology Rare Diseases One Health Initiative  

 

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing Antimicrobial Resistance Artificial Intelligence Biomarkers
Complex Innovative Trial Design Digital Health Technologies Empowering Patients and Consumers to Make Better-Informed Decisions Food Safety
Increasing Access to Complex Generic Drug Products Individualized Therapeutics and Precision Medicine Medical Countermeasures and Preparedness for Emerging Infectious Diseases Microbiome Research
Model-Informed Product Development Novel Foods and Food Ingredients Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments Product Safety Surveillance Quality of Compounded Drugs Regenerative Medicine
  Substance Use Disorders Technologies to Reduce Pathogen Contamination Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

 

Research Capabilities, Tools, and Resources

Research Management and Collaborations Technology Transfer and Public-Private Partnerships Physical Standards and Reference Materials Intramural Grant Programs Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities Professional Development and Continuing Education Communication and External Meetings

Infrastructure

Facilities and Shared Resources Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

 Contact Us: FARS@fda.hhs.gov

 

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