Food and Drug Administration Grants

Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers

Background The FDA Oncology Center of Excellence (OCE) aims to advance the development and regulation of oncology products for patients with cancer. The Pediatric Oncology Program and Rare Cancers Pro

Retail Food Safety Regulatory Association Collaboration

Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional

Cooperative Agreement to Support Shellfish Safety Assistance Project

Federal and University Partnership to Improve the Safety of Seafood from the Gulf of America

Research, Education, and Outreach on Botanical Natural Products

Education and Outreach to Tribal Producers through the Tribal Food Safety Alliance

Minor Use Minor Species Development of Drugs (R01)

Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed

NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens

Laboratory Flexible Funding Model (LFFM)

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Animal and Veterinary Innovation Centers (U18)

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Vet-LIRN Capacity-Building Project and Equipment Grants (U18)

REACHing Communities (REACH) Consortium (U01) Clinical Trials Optional

Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed

Center for Research on Complex Generics (U18) Clinical Trials Optional

Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

Manufactured Foods Flexible Funding Model (MF-FFM)

Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics

Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)

Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed

Critical Path Public Private Partnerships Clinical Trials Optional

FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)

Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs

Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)

Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed

Cooperative Agreement to Support Effective Dissemination of Clinical Practice Guidelines

NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens

Novel approaches to support therapeutic development in ultra-rare cancers

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Conformance with the Egg Regulatory Program Standards

FDA's Integrated Food Safety System Training Delivery and Development

Data Standards for Tobacco Research and Scientific Review Phase 2

Studies Addressing Rare Neurodegenerative Diseases including ALS

Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional

Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional

Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed

Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities

FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed

FDA OMHHE Convener for Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH)

Retail Food Safety Regulatory Association Collaboration

Rapid Response Team (RRT) Cooperative Agreement

Animal Food Regulatory Program Alliance

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed

Collaborations to Enhance Drug Development and Regulatory Science

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed

Integrated Food Safety System Regulatory and Laboratory Training System National Coordination Center

OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed

African Medical Devices Regulatory Harmonization Program

Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed

Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed

Food Safety Capacity and Infrastructure Building (U2F)

Minor Use Minor Species Development of Drugs (R01)

Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed

Retail Food Safety Regulatory Association Collaboration CAP

Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives

Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed