Common Contracts
1 similar Inter-Agency Agreement contracts
Inter-Agency Agreement Between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the U.S. Food and Drug Administration (FDA)Inter-Agency Agreement • July 20th, 2015
The objective of this Interagency Agreement (IAA) was to develop formulation approaches that will provide optimal approaches for pediatric drug delivery. The availability of publically available oral pediatric drug delivery approaches would have the corollary benefit of reducing the unregulated extemporaneous compounding of pediatric dosage forms, using dosage forms designed for adult patient populations, which have been responsible for numerous adverse events in the pediatric patient population. An ideal pediatric dosage form is an orally dissolvable solid; tasteless; in an appropriate dose amount that would be appropriate for pediatric patients, ranging from infant to adolescent; contain minimal amounts of safe excipients; stable in light, humidity and heat; and have the necessary release and stability characteristics, as applicable.
