Intra-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)Intra-Agency Agreement • November 2nd, 2011
Contract Type FiledNovember 2nd, 2011The objective of this work is to provide some baseline information about marketed pediatric products that have been approved for administration to pediatric patients. These products are approved either for administration to pediatric patients as-is or by reconstitution and compounding with specific instructions on the product label. A significant amount can be learned from these approved products, and the knowledge gained can be applied for the development of new formulations of new and existing active pharmaceutical ingredients (APIs).
Intra-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)Intra-Agency Agreement • November 2nd, 2011
Contract Type FiledNovember 2nd, 2011The objective of this work is to provide some baseline information about marketed pediatric products that have been approved for administration to pediatric patients. These products are approved either for administration to pediatric patients as-is or by reconstitution and compounding with specific instructions on the product label. A significant amount can be learned from these approved products, and the knowledge gained can be applied for the development of new formulations of new and existing active pharmaceutical ingredients (APIs).