Affiliation: Food and Drug Administration
- Pediatric drug labeling: improving the safety and efficacy of pediatric therapiesRosemary Roberts
Office of Counter Terrorism and Pediatric Drug Development, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20855, USA
JAMA 290:905-11. 2003..In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA), which encouraged pediatric drug development by providing an incentive in the form of additional marketing exclusivity...
- Improving pediatric dosing through pediatric initiatives: what we have learnedWilliam Rodriguez
Food and Drug Administration, 5600 Fisher Lane, Parklawn Building, Room 13B 45, Rockville, MD 20850, USA
Pediatrics 121:530-9. 2008..The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the drug labeling...
- Current regulatory policies regarding pediatric indications and exclusivityWilliam J Rodriguez
Center for Drug Evaluation and Research CDER Food and Drug Administration, Rockville, MD, USA
J Pediatr Gastroenterol Nutr 37:S40-5. 2003....
- Peer-reviewed publication of clinical trials completed for pediatric exclusivityDaniel K Benjamin
Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Rockville, MD, USA
JAMA 296:1266-73. 2006..As a result, there have been over 100 product labeling changes. The publication status of studies completed for pediatric exclusivity has not been evaluated...
- "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/riskShirley Murphy
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Counter Terrorism and Pediatric Drug Development, Silver Spring, MD 20993, USA
J Allergy Clin Immunol 117:34-9. 2006..A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted...
- Amoxicillin for postexposure inhalational anthrax in pediatrics: rationale for dosing recommendationsJohn J Alexander
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Pediatr Infect Dis J 27:955-7. 2008..5 microg/mL) over most of the dosing interval (75-100%). Doses <45 mg/kg/d and dosing intervals longer than 8 hours should not be used for postexposure inhalational anthrax...
- FDA perspective on antivirals against biothreats: communicate early and oftenRosemary Roberts
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Counter Terrorism and Emergency Coordination, 10903 New Hampshire Avenue, White Oak Campus, Silver Spring, MD 20993, United States
Antiviral Res 78:60-3. 2008..Efficient development of therapeutics against these agents requires collaborative efforts among industry, academia and federal agencies...