Regulatory Science Extramural Research and Development Projects

Emerging Technology in Medicine — Emerging Technology

Cutting-Edge Research Funded Through FDA's Advancing Regulatory Science Broad Agency Announcement (BAA)

To spur innovation in the field of regulatory science FDA funds extramural research using various contract mechanisms and grants to address broad Agency challenges within FDA's Regulatory Science Framework.

Since 2012, FDA has been soliciting proposals to advance the state of the art within these areas through a specialized contract mechanism known as FDA's Broad Agency Announcement (BAA). FDA's BAA makes it possible for us to solicit innovative ideas and approaches to developing and evaluating FDA-regulated products by tapping into external knowledge and infrastructure in areas where FDA has limited expertise or capacities. The proposals solicited from industry, academia, and other government agencies enable us to better understand the breath of innovative scientific and technical solutions available to solve difficult regulatory science problems.

BAA Announcement Due Dates for FY24 Funding Consideration

BAA Stage 1 Package Due February 19, 2024

We have received 200 complete optional early concept papers that were submitted on time. All recommendations (Submit or Do Not Submit) have been communicated to applicants that have submitted on-time and completed optional early concept papers. Reason for Do Not Submit recommendation was predominantly lack of alignment with FDA's program priorities. Please refer the Charges and Topics in Regulatory Science Framework.

If you have submitted a completed optional early concept paper and not received any follow-up communication from FDA regarding a recommendation, please contact FDABAA@fda.hhs.gov

Charge/Topic	Received	Submit	Do Not Submit
Total	200	86	114
Charge I Modernize development and evaluation of FDA-regulated products	143	60	83
A. Alternative Methods	12	3	9
B. Advanced Manufacturing Approaches	58	17	41
C. Analytical and Computational Methods	34	18	16
D. Biomarkers	8	2	6
E. Clinical Outcome Assessment	3	2	1
F. Complex and Novel Clinical Trial Design	9	4	5
G. Predictive Toxicology	1	1	0
H. Methods for Assessing Behavioral, Economic, or Human Factors	4	2	2
I. Approaches to Incorporate Patient and Consumer Input	1	1	0
J. Methods to Assess Real-World Data to serve as Real-World Evidence	11	9	2
K. Methods to Assess Data Source Interoperability	2	1	1
Charge II Strengthen post-market surveillance and labeling of FDA-regulated products	22	11	11
A. Methods to Assess Real-World Data to Support Regulatory Decision-Making	7	6	1
B. Using and Validating Artificial Intelligence Approaches	5	2	3
C. Novel Clinical Trial Design, Statistical and Epidemiologic Methods	1	0	1
D. Automated Reporting Tools for Adverse Events and Active Surveillance	4	0	4
E. Methods to Improve Communication About Risk to Patients and Consumers	1	0	1
F. Approach to Expand Data Capacity, and Increase Data Quality and Usen	2	2	0
G. Efforts to Harmonize Existing and Emerging Data Standards	2	1	1
Charge III Invigorate public health preparedness and response of the FDA, patients, and consumers	35	15	20
A. Reinforce Medical Countermeasures Initiative (MCMi)	13	3	10
B. Antimicrobial Resistance	8	2	6
C. Patient and Consumer Engagement	3	1	2
D. Substance Use and Misuse	7	6	1
E. One Health Approaches	1	1	0
F. Global Product Safety net	3	2	1
G. Emerging Technologies	0	0	0

Previous BAA Contract Awards

Featured Event

January 16, 2024: FY24 FDA Broad Agency Announcement Question and Answer Session will provide an opportunity to the applicants to learn more about the application process and next steps post submission. Join us to learn more about the FY 2024 BAA and clarify any questions on how to apply and/or what to expect after submission?

Resources For You

Office of Regulatory Science and Innovation