Funding Wizard

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 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.

Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products. To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies; along with formulation sameness and device similarity. For some OIDPs, both CCEP and PD studies can pose a challenge due to a lack of sensitivity to detect formulation differences. The purpose of this funding opportunity is to support research that will use modeling and simulation to investigate the feasibility of assessing formulation differences in regional lung exposure based on systemic PK concentration data to establish BE for OIDPs with different drug and product properties.

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 purpose of this FOA is to support a series of conferences and workshops developed with substantial FDA input to explore challenges regarding site selection of clinical trials sites in studies that are submitted to FDA for regulatory approval of oncology indications.

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2023 (FY23) to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety and public health.The purpose of this Cooperative Agreement is to:1. Contribute to the knowledge base of and development of food safety systems globally due to the increasingly diverse and complex food supply.2. Enhance and broaden FDA’s ability to address global food safety and public health issues associated with food.3. Provide opportunities to leverage additional resources of other countries.4. Support implementation of the FDA Food Safety Modernization Act (FSMA) and FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety.5. Support food safety, nutrition and public health programs that align with FDA’s mission.

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 FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional strengths of a proposed modified release drug product. The recommendations involve evidence to demonstrate the same drug release mechanism and similar dissolution profiles across strengths, as well as ratios of drug excipients across strengths that are appropriate for the drug release mechanism. The purpose of this project is to determine the critical quality attributes for different release controlling platform technologies and to determine the appropriate factors to scale the formulation for additional strengths. The outcomes of this research are intended to support generic drug development and regulatory decision making.

The purpose of this funding opportunity is to develop and validate an enhanced mechanistic PBPK model to reliably describe the skin permeation of active pharmaceutical ingredients in topical drug products applied on the skin surface of virtual subjects by accounting for the drug product quality attributes and the metamorphosis these products undergo post application. The goal is to develop an in silico tool and to assess its capability to predict skin absorption for reference listed drug and test drug products considering their potentially different formulation compositions and quality attributes and the dynamic changes they undergo post application. This in silico tool (validated using appropriate datasets) is intended to identify parameters that may impact therapeutic equivalence between a reference listed drug and a test drug product applied on the skin and to inform decisions on generic drug development for these products.

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.