Food and Drug Administration

Title Sort descending Due Date Maximum Award Amount Description
Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed $400,000.00

FDA seeks to continue a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives. This program consists of the continued development and implementation of a certified, academic training course for instruction in Good Laboratory Practices (GLP) in a Biosafety Level (BSL) 4 High Containment Environment.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=334156
Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional $2,500,000.00

The purpose of this funding opportunity announcement (FOA) is to investigate factors that can improve understanding of safety and efficacy of oncology therapeutics in populations that have been historically underrepresented in oncology trials, including racial/ethnic minorities, sex and gender minorities, and older adults.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341847
Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional $2,000,000.00

The purpose of this Funding Opportunity Announcement (FOA) is to support research projects that enhance biosimilar and interchangeable product development and regulatory science.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=345035
Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed $400,000.00

The following organization is eligible to apply:The World Health Organization (WHO)As FDA seeks to proactively work with other countries and identify research and evaluation opportunities that will impact FDA’s ability to successfully implement the Tobacco Control Act, further collaboration with WHO is anticipated. With the financial support from the U.S. FDA, WHO is uniquely qualified to undertake these activities, given its mandate, wide access to data, participation of member states, and access to worldwide regulatory expertise.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=344353
Centers of Excellence in Regulatory Science and Innovation (CERSI) $1,000,000.00

The FDA hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory Science and Innovation (ORSI), through collaborative interactions with FDA scientific experts and funding offices. This funding opportunity will provide support, depending on availability of FDA funding, for collaborative research with FDA and regulatory science information sharing opportunities.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=339588
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required $650,000.00

The purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341725
Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Clinical Trials Not Allowed $750,000.00

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2023 (FY23) to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety and public health.The purpose of this Cooperative Agreement is to:1. Contribute to the knowledge base of and development of food safety systems globally due to the increasingly diverse and complex food supply.2. Enhance and broaden FDA’s ability to address global food safety and public health issues associated with food.3. Provide opportunities to leverage additional resources of other countries.4. Support implementation of the FDA Food Safety Modernization Act (FSMA) and FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety.5. Support food safety, nutrition and public health programs that align with FDA’s mission.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=345246
Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Prescribing of Benzodiazepines $2,000,000.00

The U.S. Food and Drug Administration (FDA) seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the safe tapering of benzodiazepines. Applicants must propose a comprehensive evidence-based plan that advances safe tapering of benzodiazepines.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=340581
Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Obstetrics Pain $2,000,000.00

The U.S. Food and Drug Administration (FDA) seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the management of postoperative pain in obstetric patients who have undergone surgeries, including but not limited to cesarean delivery, vaginal delivery, and appendectomy during pregnancy. Applicants must propose a comprehensive evidence-based plan that advances safe prescribing of opioid analgesics for obstetric patients with postoperative pain.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=340616
Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act $4,500,000.00

The primary objective of this effort is to provide supporting research, identify key issues, and convene appropriate subject matter experts to help inform major regulatory science initiatives related to FDA commitments under the 2022 reauthorization of the Prescription Drug User Fee Act (PDUFA VII) and Biosimilars User Fee Act (BsUFA III).

https://www.grants.gov/web/grants/view-opportunity.html?oppId=344522