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Regulatory Science Extramural Research and Development Projects | FDA Skip to in this section menu Science and Research Special Topics Advancing Regulatory Science Regulatory Science Extramural Research and Development Projects Advancing Regulatory Science Extramural Regulatory Science - BAA ORES manages FDA-wide programs that provide funding to support extramural regulatory science and innovation to address scientific and public health priorities.
Cutting-Edge Research Funded Through FDA's Advancing Regulatory Science Broad Agency Announcement (BAA) To spur development and innovation in the field of regulatory science FDA funds extramural research using various contract mechanisms and grants to address high-priority needs within FDA's Regulatory Science Framework : Modernize development and evaluation of FDA-regulated products Strengthen post-market surveillance and labeling of FDA-regulated products Invigorate public health preparedness and response of the FDA, patients, and consumers 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) for Advanced Research and Development of Regulatory Science (Please note that SAM.
gov webpage appears with a version log. Please ensure the version in the upper-right corner for the webpage is set to the most recent date) . FDA's BAA makes it possible for us to better understand the breath of innovative scientific and technical solutions available in industry, academia, and other government agencies.
Proposals selected for award enable FDA to tap into external knowledge, capabilities, and infrastructure to solve complex regulatory science challenges. To apply for Fiscal Year (FY) 2026 funding under the BAA, applicants must submit a freestanding Concept Paper and freestanding Full Proposal in accordance with preparation guidance by February 24, 2026. Early applications are highly encouraged.
Please be informed that Optional Early Concept Paper phase has been removed from the FY26 FDA BAA Announcement posted on SAM. gov (Please note that SAM. gov webpage appears with a version log.
Please ensure the version in the upper-right corner for the webpage is set to the most recent date). Freestanding Concept Papers must describe the proposed research effort in sufficient detail to enable a high-level evaluation of the concept's technical merit and its potential contribution as well as program alignment with FDA priorities and mission.
Offerors whose freestanding Concept Paper receives a favorable high-level evaluation will have their Full Proposal evaluated by a panel of subject matter experts (technical evaluation panel). Learn more information on how to apply for funding under the FY26 BAA see SAM. gov .
January 16, 2025: FY25 FDA Broad Agency Announcement Question and Answer Session - Learn more about the FY 2025 BAA, and how to apply. Advance registration is needed. Deadline for submission# Description What to submit?
How to Submit? What to expect? 2/24/2026 (Required submission) Stage I Submittal Packages for FY26 funding consideration Checklist, Freestanding Concept Paper ($Freestanding Full Proposal (Single email with separate attachments) ~Email subject line “Charge Area_FDABAA-26-00123 Concept Paper with Full Proposal” in pdf format.
Evaluate Concept Paper and forward Full Proposal of favorable Concept Papers for review %~Email subject line “BAA Number Concept Paper with Full Proposal” in pdf format (highlight any revised fields of the Concept Paper) Review Full Proposal *2/25/2026 – 9/21/2026 *Stage I Submittal Packages for open period *Same as above *Same as above *Same as above Within 14 calendar days of FDA request^ Stage II: Revised Full Proposal Submittal Package Cover Page, Response summary to feedback, Revised Full Proposal (Single email with separate attachments) ~Email subject line “BAA Number Revised Full Proposal” in pdf format.
Highlight revisions Review of responses and revised Full Proposal Freestanding Full Proposal: Volume I Technical Proposal with appendix (attachment 5) and Volume II Cost Proposal with appendix *Open Period: Stage One Submittal Packages received after February 24, 2026 will still be accepted, but due to a lack of lead time and funding availability may not be considered for award in FY26.
These submissions may be considered for award in FY27. ^Unless designated otherwise by the Contracting Officer FY25 BAA announcement will posted on SAM.
gov on October 4, 2024 FY25 BAA Contracts Awards FY24 BAA Contracts Awards FY23 BAA Contracts Awards FY22 BAA Contracts Awards FY21 BAA Contracts Awards FY20 BAA Contracts Awards FY19 BAA Contracts Awards FY18 BAA Contracts Awards Fiscal Year BAA applications Received No. of Awarded Total Funds 2025 308 15 $16,737,952. 78 2024 278 24 $24,597,676. 28 2023 264 39 $26,606,696.
92 2022 181 45 $142,495,425. 15 2021 192 45 $46,112,948. 13 2020 196 48 $55,289,690.
12 2019 165 53 $55,266,341. 17 2018 159 39 $28,230,765. 55 2017 160 26 $29,315,334.
25 2016 86 29 $25,272,636. 27 2015 92 34 $24,055,857. 16 2014 87 28 $20,651,356.
81 Review and communication of FY24 BAA applications was completed by September 30th, 2024 . FY24 awards will be posted on sam. gov by October 4th .
January 20, 2026: FDA Broad Agency Announcement Day - Learn more about the FY 2026 BAA, and how to apply. November 14, 2024: FDA Broad Agency Announcement Day - Learn more about the FY 2025 BAA, and how to apply. 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? Office of Regulatory and Emerging Science (ORES) Descriptions of FDA BAA-funded research projects, their goals, and how they're addressing regulatory science challenges within FDA's scientific priority areas are found below.
Highlights of Extramural BAA Research Priority Area 1: Modernize Toxicology to Enhance Product Safety Priority Area 2: Stimulate Innovation in Clinical Trials Priority Area 3: Support New Approaches to Improve Product Manufacturing and Quality Priority Area 4: Ensure FDA Readiness to Evaluate Emerging Technologies Priority Area 5: Harness Diverse Data through Information Sciences to Improve Health Outcomes Priority Area 6: Implement a New Prevention-Based Food Safety System Priority Area 7: Facilitate Development of Medical Countermeasures to Protect National Health and Security Priority Area 8: Strengthen Social and Behavioral Science to Promote Informed Decision-Making About FDA-Regulated Products Priority Area 9: Strengthening the Global Product Safety Net BAA Announcement Due Dates for FY24 Funding Consideration FY24 FDA BAA Solicitation: FY 2024 BAA solicitation version 6 published January 25th, 2024, includes updated information for Stage I package preparation.
Scope added to Charge I, Topic I for Devices and Charge III, Topic F for Drugs (amendments indicated with #) Please note that the BAA Stage I package is due on February 20, 2024, for FY 2024 funding considerations. Stage I package* submission: Submissions in PDF format only and email (separate attachments in same email) to FDABAA@fda. hhs.
gov with email subject for New submissions as “Charge Area_FDABAA-24-00123 Concept Paper with Full Proposal” and Recommended Submissions as “BAA Number Concept Paper with Full Proposal”.
*Stage I package submission MUST include: Freestanding Concept Paper Freestanding Full Proposal- Volume I: Technical Proposal and Volume II: Cost Proposal ( Volume I and II can be submitted as separate files) If FDA recommended a Stage I Package Submission (for Optional Early Concept Paper submissions): A revised concept paper may be submitted and the submitted version should highlight any fields that were revised from the version of the Optional Early Concept Paper Provide primary research area and BAA number in concept paper and email See Part III: Proposal Preparation and Submission of the FY 2024 BAA solicitation for additional information on Stage One package preparation.
We have received 202 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 I Modernize development and evaluation of FDA-regulated products B. Advanced Manufacturing Approaches C. Analytical and Computational Methods E.
Clinical Outcome Assessment F. Complex and Novel Clinical Trial Design H. Methods for Assessing Behavioral, Economic, or Human Factors I.
Approaches to Incorporate Patient and Consumer Input J. Methods to Assess Real-World Data to serve as Real-World Evidence K. Methods to Assess Data Source Interoperability Charge II Strengthen post-market surveillance and labeling of FDA-regulated products A.
Methods to Assess Real-World Data to Support Regulatory Decision-Making B. Using and Validating Artificial Intelligence Approaches C. Novel Clinical Trial Design, Statistical and Epidemiologic Methods D.
Automated Reporting Tools for Adverse Events and Active Surveillance E. Methods to Improve Communication About Risk to Patients and Consumers F. Approach to Expand Data Capacity, and Increase Data Quality and Usen G.
Efforts to Harmonize Existing and Emerging Data Standards Charge III Invigorate public health preparedness and response of the FDA, patients, and consumers A. Reinforce Medical Countermeasures Initiative (MCMi) B. Antimicrobial Resistance C.
Patient and Consumer Engagement D. Substance Use and Misuse F. Global Product Safety net
According to the current listing, eligibility includes: Academic institutions, nonprofit organizations, and small businesses. Confirm the full requirements in the official notice before applying.
FDA Regulatory Science Research Grants is funded by FDA. Verify program details on the funder's official page before applying.
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Diversification of nutritional food ingredient sources for increased EU resilience and strategic autonomy is sponsored by European Commission — Horizon Europe. Expected Outcome: Successful proposals will contribute to the implementation of the EU initiative on Biotechnology and Biomanufacturing and the EU Life Sciences Strategy as well as the updated EU Bioeconomy Strategy, the upcoming EU Biotechnology Act and EU Circular Economy Act. Projects’ results are expected to contribute to the following expected outcomes: Full industrial scale biorefinery and related value chain(s) for the production of nutritional food ingredients. Resilience and strategic autonomy of EU food sectors via diversification of nutritional food ingredient sources. Increased environmental sustainability of food sectors (e.g. addressing issues like land use, water use, energy consumption, nitrogen cycle, other nutrients, etc.). Improved consumers awareness and acceptance of nutritional food ingredients from alternative sources, contributing to sustainable healthy diets. Scope: Human nutrition is a key area where the bio-based industries can play an important role in addressing the present societal and climate challenges. Considerable attention is given to the utilisation of alternative sources of proteins, fibres and oils/fats, due to the increasing world population and the pressure on finite natural resources. Many sources for food ingredients, alternative to agricultural crops, exist and have been successfully piloted across the EU. However, efforts are needed to scale up sustainable processes to achieve adequate or even improved nutritional properties, ensure safety and consumers/end users acceptance, while achieving cost competitiveness. Proposals under this topic should: Demonstrate (at TRL 8) the efficient production of nutritional ingredients for food applications. Proteins, lipids, specialty carbohydrates, and fibres are in scope. Target at least one of these as the main product driving the business case. Structural or functional ingredients such as colourants, preservatives, stabilisers, texturisers, enzymes are not in scope as the main product. Synergistic co-production of multiple and different food and feed ingredients and other bio-based products is also in scope following the cascading approach. All sources of bio-based feedstock [1] are in scope. Direct production of food from food crops, livestock, fisheries and aquaculture is not in scope. The use of industrial grade feedstock [2] from agricultural crops is in scope for conversion into food grade ingredients. Validate (at TRL 6 and above) the use of the obtained nutritional food ingredient(s) into the formulation of at least 1 food product proving quality, stability, nutritional and sensorial properties. Additional aspects related to prevention of intolerances/allergies, improved palatability and digestibility, health benefits, etc. are also in scope depending on the ingredient(s), formulation(s) and product(s) developed. Address resource efficiency and circularity aspects to increase economic and socio-environmental added value. When pursuing circular models, ensure that neither pathogens nor contaminants are injected back in the loop, to avoid negative toxicological effects. In addition to the specific requirements applicable for the type of action, as described in section 2.2.3.1 of the CBE JU Annual Work Programme 2026 [3] , proposals under this topic should: Assess the safety of developed nutritional food ingredients, in line with EU regulatory requirements and EFSA guidance documents. Moreover, identify potential EU regulatory gaps and propose recommendations to relevant EU policymakers on how to better support food ingredient companies (including startups and scaleups) in addressing EFSA risk assessment. As part of the multi-actor approach (MAA), involve end-users (including consumers) and other relevant actors starting from the early stages to gather input, raise awareness and ultimately foster market acceptance of the targeted end-products and incorporate insights into product development. Ensure complementarities and avoid overlaps with Programme areas: Global Challenges and European Industrial Competitiveness, Food, Bioeconomy Natural Resources, Agriculture and Environment, Bio-based Innovation Systems in the EU Bioeconomy, Horizon Europe (HORIZON) Keywords: Agricultural biotechnology and food biotechnology, Agricultural engineering, food safety, Food biotechnology, alternative sources, carbohydrates, circular economy, fibres, food ingredients, food products, food safety, lipids, nutrition, proteins, STEP-Biotech
Boosting biorefinery competitiveness through biotech is sponsored by European Commission — Horizon Europe. Expected Outcome: Successful proposals will contribute to the implementation of the EU initiative on Biotechnology and Biomanufacturing, the EU Life Sciences Strategy, the updated EU Bioeconomy Strategy, the EU Biotechnology Act, the Clean Industrial Deal, the European Chemical Industry Action Plan and the upcoming EU Circular Economy Act. Projects results are expected to contribute to the following expected outcomes: Full industrial scale biorefinery and related value chain(s) for the sustainable production of bio-based products using biotech as a key enabling technology. Availability of bio-based products meeting market and technical performance requirements as relevant for their respective application areas. Improvement of sustainability, circularity and resource efficiency compared to relevant benchmark(s). Contribution to increasing the EU’s strategic autonomy, resilience and competitiveness. Scope: Biorefineries integrating biotechnologies, underpinned by sustainably sourced bio-based feedstock, have a huge potential to transform the EU manufacturing landscape, spurring socio-economic growth, fostering job creation and contributing to defossilisation of the EU economy. Europe is strong in life sciences including industrial biotechnology. However, research results often struggle to be deployed to the market; in most cases, scale-up needs de-risking and requires overcoming challenges in large-scale process and reactor design, cell productivity, efficient use of feedstock, operative condition stability, reactor sterility and efficient integration of downstream operations among others. Proposals under this topic should: Demonstrate (at TRL 8) a sustainable and robust biomanufacturing route to obtain bio-based product(s). The proposal should focus on processes in which biotechnology is the key enabling technology; the integration of (upstream and/or downstream) supporting unit operations based on technologies other than biotechnology is in scope. Products in scope include chemicals, intermediates, polymers, ingredients and enzymes. Food and feed ingredients as main application are out of scope. Optimisation of selected cells, enzymes and/or microorganisms is also in scope provided that the starting TRL is at least 6. Demonstrate (at TRL 8) the further conversion or use of the obtained biorefinery product(s) into at least one end-product driving the business case; validate it (TRL 6 and above) in relevant market applications. Additional end-product(s) with high prospective market potential can be targeted, reaching at least TRL 6. In addition to the specific requirements applicable for the type of action, as described in section 2.2.3.1 of the CBE JU Annual Work Programme 2026 [1] , proposals under this topic should: As part of the multi-actor approach (MAA), ensure adequate involvement of all key actors in the value chains relevant for this topic and across the sustainable circular bio-based system, including feedstock providers, policymakers and end users. Address compliance with EU regulatory frameworks as relevant for targeted products and applications, identify potential gaps and provide recommendations to overcome them. Perform a risk assessment on impacts, potentially deriving from the use of biotechnology, on human and ecosystem safety and identify adequate mitigation measures. Assess the adequacy of policy and regulatory means to manage these risks and provide recommendations to overcome potential identified bottlenecks. Include a task to apply the SSbD framework, developed by the European Commission, for the assessment of the production process of targeted biorefinery product(s) as well as the chosen derived end product(s). For more information on the SSbD framework and criteria, refer to Safe and sustainable by design . Seek complementarities and avoid overlaps with past and ongoing R&I projects addressing similar challenges, including those funded by BBI JU/CBE JU and under Horizon 2020/Horizon Europe (under Cl Programme areas: Global Challenges and European Industrial Competitiveness, Food, Bioeconomy Natural Resources, Agriculture and Environment, Bio-based Innovation Systems in the EU Bioeconomy, Horizon Europe (HORIZON) Keywords: Applied and industrial chemistry, Bioprocessing technologies (industrial processes relying on biological agents to drive the process) biocatalysis, fermentation, Industrial bioengineering, Industrial biotechnology, bio-based feedstock, bio-based products, bio-conversion, bioreactors, biorefineries, downstream technologies, safe and sustainable by design, STEP-Biotech