The PPRU Network sites are conducting clinical studies in a wide array of therapeutic areas as shown in Figure 1. Current therapeutic categories include antivirals, antibiotics, antifungals, antiinflamatory agents, gastrointestinal drugs, analgesics, anti-diabetic agents, antipyretics, hormone analogues and antagonists, and new psychoactive agents. PPRU Network studies are well distributed across all pediatric age groups. Because of the unique expertise of our investigators, 24% of the studies involve children under two years of age, including newborns and infants. AREAS OF EXPERTISE: For a printable version of all areas of expertise click here Spectrum Capability to conduct Phase I - IV clinical pharmacology trials that conform to GCP/ICH regulatory requirements in a safe, effective and timely fashion; to generate a high percentage (> 95%) of "evaluable subjects" in each trial; and to produce data that has enabled expanded labeling of drugs for pediatric patients. Investigator Expertise Access to a group of academic pediatric clinical pharmacologists in the U.S. who can provide expert consultation regarding protocol development and design. Access to a group of highly skilled pediatric clinical research professionals and sub specialists who, under the imprimatur of NIH, work together to effectively take a study from concept/ protocol design through implementation, data analysis and report generation. Patient Resources Access to large all-inclusive pediatric population, ranging in age from birth through young adulthood, with approximately 177,000 pediatric inpatient admissions and over two million outpatient visits annually. Interface with the FDA The NICHD has had a longstanding relationship with FDA's Center for Drug Evaluation and Research. The two agencies hold monthly meetings with CDER's Associate Director for Pediatrics and staff to address issues related to the implementation of FDAMA and the determination of research needs in pediatric clinical trial methodology. The identified research needs are being addressed by the investigators of the PPRU Network. For more information regarding PPRU's affiliation with CDER, please follow this link: http://www.fda.gov/cder/pediatric/ped-org.htm Operation Center A Network Operations Center that serves as a central point of contact for the participating sites to facilitate communication and responsiveness.