Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi‐Stakeholder Think Tank

Author:

Torok Rachel D.1,Li Jennifer S.1,Kannankeril Prince J.2,Atz Andrew M.3,Bishai Raafat4,Bolotin Ellen5,Breitenstein Stefanie5,Chen Cathy6,Diacovo Thomas7,Feltes Timothy8,Furlong Patricia9,Hanna Michael10,Graham Eric M.3,Hsu Daphne11,Ivy D. Dunbar12,Murphy Dianne13,Kammerman Lisa A.4,Kearns Gregory14,Lawrence John10,Lebeaut Brigitte6,Li Danshi10,Male Christoph15,McCrindle Brian16,Mugnier Pierre10,Newburger Jane W.17,Pearson Gail D.18,Peiris Vasum13,Percival Lisa10,Pina Miriam19,Portman Ronald20,Shaddy Robert21,Stockbridge Norman L.13,Temple Robert13,Hill Kevin D.1

Affiliation:

1. Duke University and the Duke Clinical Research Institute, Durham, NC

2. Vanderbilt University Medical Center, Nashville, TN

3. Medical University of South Carolina, Charleston, SC

4. AstraZeneca, Gaithersburg, MD

5. Bayer AG, Whippany, NJ

6. Daiichi Sankyo, Parsippany, NJ

7. Columbia University Medical Center, New York, NY

8. Nationwide Children's Hospital, Columbus, OH

9. Parent Project Muscular Dystrophy, Middletown, OH

10. Bristol‐Myers Squibb, Princeton, NJ

11. Albert Einstein College of Medicine, New York, NY

12. Children's Hospital of Colorado, Aurora, CO

13. US Food and Drug Administration , Silver Spring, MD

14. Arkansas Children's Hospital, Little Rock, AR

15. Medical University of Vienna, Austria

16. University of Toronto, Canada

17. Boston Children's Hospital, Boston, MA

18. US National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD

19. Janssen Pharmaceuticals, Raritan, NJ

20. Novartis Pharmaceuticals, East Hanover, NJ

21. Children's Hospital of Los Angeles, CA

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Reference58 articles.

1. An update on the therapeutic orphan;Wilson JT;Pediatrics,1999

2. Clinical trials in children

3. United States Food and Drug Administration Pediatric Product Development. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm. Accessed June 30 2017.

4. European Medicines Agency Paediatric Regulation. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000068.jsp&mid=WC0b01ac0580925c45. Accessed April 26 2016.

5. Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Institute of Medicine ; Field MJ Boat TF editors. Safe and Effective Medicines for Children. Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Washington DC: National Academies Press; 2012.

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