WASHINGTON, Jan. 13 -- U.S. Department of Health and Human Services' Food and Drug Administration announced that it expects to award cooperative agreements for the enhancement of regulatory standard of gastro-retentive extended release formulation. The agency description of the cooperative agreement states: "Gastro-retentive dosage forms are designed to have a prolonged residence time in the upper gastrointestinal tract to enhance bioavailability. However there has been no direct evidence of ga more ST

WASHINGTON, Jan. 14 -- The U.S. Department of Health and Human Services' Food and Drug Administration announced that it expects to award cooperative agreements for the evaluation of the adhesion performance of transdermal and topical delivery systems. The agency description of the cooperative agreement states: "The purpose of this funding opportunity is to support the research to develop in vitro test methods for Transdermal and Topical delivery systems (collectively, TDS) that can correlate wi more ST

WASHINGTON, Jan. 14 -- The U.S. Department of Health and Human Services' Food and Drug Administration announced that it expects to award cooperative agreements for the deconstruction of data and standards to support harmonization and interoperability for clinical research. The agency description of the cooperative agreement states: "Data concepts (not just the information but the underlying definition of its meaning) between many different sources of real-world data (RWD) (e.g., EHRs, Claims, a more ST

WASHINGTON, Jan. 14 -- The U.S. Department of Health and Human Services' Food and Drug Administration announced that it expects to award a cooperative agreement for the development of a physiologically based pharmacokinetic model for nose-to-brain drug delivery. The agency description of the cooperative agreement states: "Nasal drug products are typically designed to target either local or systemic pharmacokinetics (PK) following deposition of the inhaled aerosol. However, an emerging target fo more ST

WASHINGTON, Jan. 14 -- The U.S. Department of Health and Human Services' Food and Drug Administration announced that it expects to award cooperative agreements for the development of advanced analytical methods for the characterization of complex generics. The agency description of the cooperative agreement states: "Advanced analytical methods for characterization and comparative analysis of complex products, which help to link product attributes to product quality, safety and efficacy, are use more ST

WASHINGTON, Jan. 14 -- The U.S. Department of Health and Human Services' Food and Drug Administration announced that it expects to award up to two cooperative agreements for the assessment of bioequivalence of locally-acting drugs in the gastrointestinal tract. The agency description of the cooperative agreement states: "One specific objective of this project is to identify product quality attributes (formulation variables) and physiological or pathological variables that can influence the loca more ST