Table 1.pdf
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- FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Solicitation number
- FDABAA-24-00123
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This document contains a Broad Agency Announcement from the Food and Drug Administration seeking regulatory science research proposals. The FDA is soliciting proposals through October 25, 2023 to support three priority areas: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Funded research should advance scientific knowledge in areas like alternative methods, clinical outcomes assessment, predictive toxicology, real-world data, artificial intelligence, and global product safety to aid the FDA's mission of protecting public health.
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Text version
Table 1: Areas of regulatory science research priority for FDA in FY 24. For each charge (rows), the “x” marks priority areas for relevant FDA regulated product areas, and demographics & populations (columns). Cr os s-cu tti ng Bi ol og ics Bi os im ila rs
De vi ce s Dr ug s
To ba cc o
Pr od uc ts
Ra cia l a nd
Et hn ic
W om en Pe rs on s w ith
Ra re D ise as es Pe rs on s w ith ca nc er s
A. Alternative Methods X X X X X B. Advanced Manufacturing Approaches X X X X X C. Analytical and Computational Methods X X X X X X X X X X D. Biomarkers X X X X X X E. Clinical Outcome Assessment (COA) X X X X X F. Complex and Novel Clinical Trial Design X X X X X X X G. Predictive Toxicology X X X X X H. Methods for Assessing Be havioral, Economic, or Human Factors
X X X
I. Approaches to Incorporate Patient and Consumer Input
X
J. Methods to Assess Real-World Data to serve as Real-World Evidence
X X X X X X X
K. Methods to Assess Data Source Interoperability
X
A. Methods to Assess Real-World Data to Support Regulatory Decision-Making
X X X X X
B. Using and Validating Artificial Intelligence Approaches
X X X X
C. Novel Clinical Trial Design, Statistical and Epidemiologic Methods
X X
D. Automated Reporting Tools for Adverse Events and Active Surveillance
X X X X
E. Methods to Improve Communication About Risk to Patients and Consumers
X X X X
F. Approach to Expand Data Capacity, and Increase Data Quality and Use
X X X
G. Efforts to Harmonize Existing and Emerging Data Standards
X
A. Reinforce Medical Countermeasures Initiative to Increase Preparedness and Response for Emerging Public Health Threats
X X X X
B. Antimicrobial Resistance X
C. Patient and Consumer Engagement X X X D. Substance Use and Misuse X X X X E. One Health Approaches X F. Strengthen Global Product Safety Net X X X G. Emerging Technologies X
FDA-Regulated Areas
Demographics & Populations
I. Modernize development and evaluation of FDA-regulated products
II. Strengthen post-market surveillance and labeling of FDA-regulated products
III. Invigorate public health preparedness and response of the FDA, patients, and consumers
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