Rosemary Roberts

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi Pediatric drug labeling: improving the safety and efficacy of pediatric therapies
    Rosemary 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
  2. ncbi Improving pediatric dosing through pediatric initiatives: what we have learned
    William Rodriguez
    Food and Drug Administration, 5600 Fisher Lane, Parklawn Building, Room 13B 45, Rockville, MD 20850, USA
    Pediatrics 121:530-9. 2008
  3. ncbi Current regulatory policies regarding pediatric indications and exclusivity
    William J Rodriguez
    Center for Drug Evaluation and Research (CDER) Food and Drug Administration, Rockville, MD, USA
    J Pediatr Gastroenterol Nutr 37:S40-5. 2003
  4. ncbi Peer-reviewed publication of clinical trials completed for pediatric exclusivity
    Daniel K Benjamin
    Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Rockville, MD, USA
    JAMA 296:1266-73. 2006
  5. ncbi "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
    Shirley 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
  6. ncbi Amoxicillin for postexposure inhalational anthrax in pediatrics: rationale for dosing recommendations
    John J Alexander
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Pediatr Infect Dis J 27:955-7. 2008
  7. ncbi FDA perspective on antivirals against biothreats: communicate early and often
    Rosemary 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

Collaborators

  • Shirley Murphy
  • Lisa Mathis
  • Jennifer S Li
  • Daniel K Benjamin
  • Robert M Califf
  • William J Rodriguez
  • John J Alexander
  • William Rodriguez
  • Dianne Murphy
  • Hari Cheryl Sachs
  • Jennifer Di Giacinto
  • Shiew-Mei Huang
  • Peter Lee
  • Veneeta Tandon
  • Debbie Avant
  • Sandra Suarez
  • Gerlie Gieser
  • Shiew Mei Huang
  • Philip M Colangelo
  • Arzu Selen
  • Charles K Cooper
  • Terrie Crescenzi
  • Ramana S Uppoor
  • Mary D Murphy
  • Chandra Chaurasia

Detail Information

Publications7

  1. ncbi Pediatric drug labeling: improving the safety and efficacy of pediatric therapies
    Rosemary 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...
  2. ncbi Improving pediatric dosing through pediatric initiatives: what we have learned
    William 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...
  3. ncbi Current regulatory policies regarding pediatric indications and exclusivity
    William J Rodriguez
    Center for Drug Evaluation and Research (CDER) Food and Drug Administration, Rockville, MD, USA
    J Pediatr Gastroenterol Nutr 37:S40-5. 2003
    ....
  4. ncbi Peer-reviewed publication of clinical trials completed for pediatric exclusivity
    Daniel 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...
  5. ncbi "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
    Shirley 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...
  6. ncbi Amoxicillin for postexposure inhalational anthrax in pediatrics: rationale for dosing recommendations
    John 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...
  7. ncbi FDA perspective on antivirals against biothreats: communicate early and often
    Rosemary 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...