The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK)...more
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...more
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...more
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...more
The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional...more
FDA is announcing its intention to accept and consider a renewal application for a cooperative agreement, with the availability of approximately $105,000 in total fiscal year (FY) 2023 funds, in...more
The purpose of this funding opportunity announcement (FOA) is to fund COVID research that will strengthen and advance research in minority health and healthy equity, increase understanding of health...more
The following organization is eligible to apply:The World Health Organization (WHO)As FDA seeks to proactively work with other countries and identify research and evaluation opportunities that will...more
The FDA hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs...more
The Republic of Rwanda has been picked as one of the six African countries as beneficiaries for a new fellowship fund program designed at supporting social entrepreneurs in tackling issues on food security.