Collaborations to Enhance Drug Development and Regulatory Science

The Food and Drug Administration is seeking applications for a cooperative agreement under the Critical Path Initiative to advance regulatory science and foster Public-Private Partnerships that enhance drug development. The initiative aims to support innovative, collaborative projects in research, education, and outreach that accelerate the development of drug products, promote advanced manufacturing techniques, translate basic scientific discoveries into viable therapeutics, and improve the safety, efficacy, quality, and performance of pharmaceuticals. Projects will be identified and prioritized by the FDA based on current drug development priorities, and multiple awards may be issued contingent on funding availability and strategic alignment with agency goals. The partnership between the FDA and grantees will be collaborative, with both parties working together to design and execute initiatives that bridge gaps in the drug development pipeline. This opportunity is open to organizations capable of facilitating multi-stakeholder collaboration and driving progress in regulatory science. All activities must align with the objectives of the Critical Path Initiative as authorized under Title 21, Section 360bbb-5 of the U.S. Code. The funding opportunity was posted on November 30, 2023, and inquiries can be directed to Terrin Brown at the FDA, who serves as the primary point of contact for grant-related matters. There are no set-asides specified, and the award is not tied to a specific NAICS code or organizational type, allowing a broad range of entities to apply. Performance of the funded activities may occur anywhere in the United States, with no specific location requirement outlined.