Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial Not Allowed

Food and Drug Administration
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP) is announcing the availability of a cooperative agreement to be awarded under a Limited...more

Drug Development Tools Research Grants (U01 Clinical Trial Optional)

Food and Drug Administration
Drug development tools (DDTs) are methods, materials, or measures that can potentially facilitate drug development. To support DDT development efforts, FDA established qualification programs for...more

Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional)

Food and Drug Administration
Recently FDA launched a series of strategic efforts designed to improve the national capacity to study use and impact of medical devices in the real-world setting. FDA is collaborating with medical...more

Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed

Food and Drug Administration
Background:Levonorgestrel-releasing intrauterine system (IUS) is a type of complex drug product with multiple complexities: it is a long acting product (with drug release up to 5 years), it is...more

Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional

Food and Drug Administration
BackgroundFDA regulates pharmaceutical drug products to ensure a continuous supply of high quality drugs in the United States. In regulating the pharmaceutical manufacturing sector, new technologies...more

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

Food and Drug Administration
Background The FDA's Office of Generic Drugs (OGD) implements the generic drug research program under the Generic Drug User Fee Amendments (GDUFA) in part by collaborating externally with...more

International Emergency Food Assistance

Agency for International Development
The U.S. Agency for International Development’s (USAID) Office of Food for Peace (FFP) is the U.S. Government (USG) leader in international food assistance. The purpose of this Annual Program...more

Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials Not Allowed

Food and Drug Administration
The FDA Center of Drug Evaluation and Research (CDER) is encouraging applications to explore the development of how Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) data...more

Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed

Food and Drug Administration
BackgroundFor approval, a generic drug product must demonstrate it is bioequivalent (BE) to the (brand name) reference listed drug (RLD) product. For locally acting drug products, where conventional...more