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FDA Funding Opportunity for Research on Digital Health Technologies in Drug and Biologic Development (RFA-FD-26-012) is sponsored by U.S. Food and Drug Administration (FDA). The FDA is offering a grant funding opportunity focused on research addressing key questions about the use of digital health technologies (DHTs) in clinical investigations supporting drug and biologic development.
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Digital Health Technologies (DHTs) for Drug Development | FDA Skip to in this section menu Science and Research Special Topics Digital Health Technologies (DHTs) for Drug Development Science and Research Special Topics FDA Announces Funding Opportunity for Digital Health Technologies The U.S. Food and Drug Administration announced a funding opportunity, open July 20, 2026 – August 20, 2026, for selected applicants to explore the role of digital health technologies (DHTs) (e.g., actigraphy, photography, contactless sensors) in drug development.
Projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups and other stakeholders.
The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations.
The scope includes, but is not limited to, projects that focus on: Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of contactless room sensors to capture apnea in pediatric patients) Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) Capturing early manifestations of chronic diseases (e.g., non-memory related signs of dementia) through the use of DHTs (e.g., tests of balance or slowed reaction time) For more information, please see RFA-FD-26-012 Join Us!
FDA to host a public workshop on DHTs and statistical considerations for digitally-derived endpoints in clinical trials On Thursday, August 27, 2026, join the FDA for a free virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products.
Speakers will provide updates on FDA efforts under PDUFA VII to advance the use of digital health technologies (DHTs) in drug development and regulatory review. Discussions will also explore opportunities to strengthen data standards and innovative analytical methods that support the broader use of clinically meaningful, digitally-derived endpoints in clinical trials for drug and biological products.
Speakers will also discuss the Submitting Continuous Glucose Monitoring Data in Clinical Trials Technical Specifications Document to provide foundational background for regulatory submissions for drug and biological product evaluation, device performance assessment, and analytical best practices. Learn more and register here .
Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial data directly from patients.
Portable DHTs that may be worn, implanted, ingested, or placed in the environment allow real-time collection of data from trial participants in their homes or at locations remote from clinical trial sites.
Potential advantages of these DHTs include the ability to: make continuous or frequent measurements of clinical features record or measure novel clinical features that could not be captured during traditional study visits decentralize clinical trial activities by obtaining clinical data from study participants remotely FDA is committed to supporting the use of DHTs in clinical drug development and has developed a comprehensive program to engage with interested parties in this important scientific area.
The Prescription Drug User Fee Act VII has outlined several activities related to DHTs for drug development and review, which FDA has committed to undertake.
These activities include: Publishing a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development Establishing a DHT Steering Committee Convening Public Meetings Identifying Demonstration Projects Sections 3606 and 3607 of the Food and Drug Omnibus Reform Act of 2022 outline additional requirements for FDA to publish guidance regarding the modernization of clinical trials through decentralized clinical trials and DHTs.
The CDRH Digital Health Center of Excellence , which was established to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation, can also serve as a resource on DHTs, including their regulatory status, for sponsors, DHT manufacturers, and other stakeholders.
Framework for the Use of DHTs in Drug and Biological Product Development As part of our PDUFA VII commitment, FDA developed a framework, titled Framework for the Use of DHTs in Drug and Biological Product Development .
The program will include workshops and demonstration projects; engagement with interested parties; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents.
As part of our PDUFA VII commitments, FDA has established the DHT Steering Committee which consists of senior staff from CDER, CBER, and CDRH, including the Digital Health Center of Excellence, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs.
The Steering Committee will support the implementation of the framework for the use of DHTs in drug and biological product development as well as other commitments identified in the section “Enhancing Use of Digital Health Technologies to Support Drug Development and Review” of the PDUFA VII commitment letter (e.g., public meetings, guidance documents, demonstration projects, technology needs, training).
In addition, the Steering Committee will oversee activities to assist organizational units with consistent approaches to the review of drug submissions that contain DHT-derived data. Further, the Steering Committee will engage with external interested parties on DHT-related issues in human drug development and gather information about the present state of DHTs, including specific challenges in their use.
FDA encourages interested parties who are considering the use of DHTs in drug development or conducting a decentralized clinical trials (DCTs) to reach out to the agency early. Click on Meeting with FDA to learn more about when and how to engage FDA.
Public Meetings/ Workshops Meeting our PDUFA VII Commitment By the end of the 2nd quarter of fiscal year 2023, FDA will convene the first of a series of five public meetings or workshops with key stakeholders, including patients, biopharmaceutical companies, DHT developers, and academia, to gather input on issues related to the use of DHTs in regulatory decision-making related to drug and biological product development.
June 24-25, 2024: Joint FDA/FNIH Workshop for Digital Measures March 28-29, 2023: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review June 20, 2023: SBIA Webinar : Decentralized Clinical Trials (DCT) Draft Guidance Feb 10, 2022: SBIA Webinar : Digital Health Technologies for Remote Data Acquisition Draft Guidance Digital Health Technologies for Remote Acquisition in Clinical Investigations Decentralized Clinical Trials for Drugs, Biological Products, and Devices Framework for the Use of DHTs in Drug and Biological Product Development Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Guidances with Digital Health Content Guidance Snapshot: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Final, issued 12/22/2023).
Resources include a snapshot about the guidance , a recap podcast , and the podcast transcript .
PDUFA VII IT and Bioinformatics Goals and Progress CDRH Digital Health Center of Excellence FDA Digital Health Regulatory Policies CDER's Drug Development Tools (DDT) Qualification Program s Innovative Science and Technology Approaches for New Drugs (ISTAND) Program CDRH’s Medical Device Development Tools (MDDT) Qualification Programs For more information about DHTs for Drug Development, please email DHTsforDrugDevelopment@fda. hhs.
gov . For information about devices and to engage the Digital Health Center of Excellence, send an email to digitalhealth@fda. hhs.
gov
According to the current listing, eligibility includes: Applications are open to for-profit and nonprofit organizations, higher education institutions, and local governments, among others. Non-U. S. entities are not eligible to apply. Confirm the full requirements in the official notice before applying.
Applications for FDA Funding Opportunity for Research on Digital Health Technologies in Drug and Biologic Development (RFA-FD-26-012) are due August 20, 2026. Build your timeline backwards from this date to cover registrations, approvals, and final submission checks.
FDA Funding Opportunity for Research on Digital Health Technologies in Drug and Biologic Development (RFA-FD-26-012) is funded by U.S. Food and Drug Administration (FDA). Verify program details on the funder's official page before applying.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
Minor Use Minor Species Development of Drugs (R01) (PAR-24-216) is sponsored by U.S. Food and Drug Administration (FDA) / National Institutes of Health (NIH). This grant supports the development and potential approval of new animal drugs for uncommon diseases (minor uses) in major species or to treat minor species. It covers routine safety, effectiveness, manufacturing, and toxicology studies.
Minor Use Minor Species Development of Drugs (R01) is sponsored by U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). This grant supports the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) or to treat minor species.
NCI Continuing Umbrella of Research Experiences (CURE) Academic Career Excellence (ACE) Award (K32) is a grant from the National Cancer Institute (NCI) that funds early postdoctoral fellows from diverse backgrounds, including underrepresented groups, to pursue research training in cancer-related fields. The K32 award supports fellows within 12 months prior to transitioning into, or within the first two years of, a postdoctoral position. The program, operated through NCI's Center to Reduce Cancer Health Disparities (CRCHD), aims to enhance the pool of qualified diverse cancer researchers. Beginning with the June 12, 2025 due date, the CURE ACE Award is available in both Independent Clinical Trial Required and Independent Clinical Trial Not Allowed versions. Eligible applicants must be U.S. citizens or permanent residents at time of award.
Smart Health and Biomedical Research in the Era of Artificial Intelligence and Advanced Data Science (SCH) is sponsored by National Science Foundation (NSF) & National Institutes of Health (NIH). This interagency program supports high-risk, high-reward interdisciplinary projects that leverage AI, machine learning, and advanced data science to address pressing questions in biomedical and public health research. It seeks to advance fundamental scientific and engineering contributions across disciplines to solve key health problems.
Missouri's Department of Agriculture has reopened its Urban Agriculture Cost-Share Grant — reimbursing 75% of project costs up to $10,000, with applications due September 15, 2026. A companion Food Insecure Cost-Share Grant closes August 26. Here is how these small, fast state grants work, who qualifies under the Census 'urban area' definition, and how to layer them with the federal USDA Urban Agriculture and Innovative Production program for a durable urban-farming funding strategy.
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Read articleARPA-H's FASTPASS program targets a public-health blind spot: substandard and contaminated drugs that are only caught after patients are exposed. It funds through-package chemical sensing (TA1 SAMPLE) and the analytics to act on it (TA2 DETECT). The solicitation posts to SAM.gov in mid-August 2026, with a virtual Proposer Workshop on August 24 and registration closing August 20. Here is what FASTPASS funds, why the timing matters, and how to position a cross-disciplinary team.
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