Funding Wizard

The purpose of this Funding Opportunity Announcement (FOA) is to address topics related to FDA's Real-World Evidence (RWE) Program and to enable FDA to assess the potential utility of real-world data (RWD) in generating RWE.

The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA is issued by the FDA's Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare. Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generations of devices. In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development. As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients.Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 814.3(s)).

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).

The purpose of this NOFO is to encourage new approaches to support therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers.

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.

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

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies and/or biomarker studies that fill unmet needs for rare neurodegenerative diseases for children and adults. Through the support of prospective natural history and/or biomarker studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.

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.

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.

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereochemically-controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereochemically pure form; 2) assessment of the biological activity of each stereochemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.