The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
The grant program is designed to support, manage, and facilitate Public-Private Partnerships and Collaborative activities that align with the Critical Path Initiative to promote regulatory science efforts. Its broad goals include fostering drug product innovation through the support of efforts to accelerate drug product development, advanced manufacturing approaches, the translation of basic science discoveries into therapeutics, and enhancing the safety, efficacy, quality, and performance of drug products. The FDA will collaborate with grantees to develop projects in these areas, identifying projects that align with drug development priorities. The availability of multiple awards under this Notice of Funding Opportunity (NOFO) is contingent on these priorities and the availability of funding.