Adebowale, A. 2002. Clinical pharmacology and biopharmaceutics review(s) for children’s Advil cold suspension (ibuprofen and pseudoephedrine). NDA 21373. April 5. Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-373_Ibuprofen%20Pseudoephedrine_biopharmr.pdf (accessed March 23, 2012).
Akinbami, L. 2006. Health E-Stat: Asthma prevalence, health care use and mortality: United States, 2003-2005. Atlanta, GA: Centers for Disease Control and Prevention Publications and Information Products. http://www.cdc.gov/nchs/data/hestat/asthma03-05/asthma03-05.htm (accessed March 23, 2012).
Alivisatos, R. 2008. Medical officer review of supplemental labeling revisions (prior approval) for Retrovir (zidovudine, ZDV). NDA 19910/19655/20518. September 18. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm072896.pdf (accessed March 23, 2012).
Anand, K. J. S., J. V. Aranda, C. B. Berde, S. Buckman, E. V. Capparelli, W. A. Carlo, P. Hummel, J. Lantos, C. C. Johnston, V. T. Lehr, A. M. Lynn, L. G. Maxwell, T. F. Oberlander, T. N. K. Raju, S. G. Soriano, A. Taddio, and G. A. Walco. 2005. Analgesia and anesthesia for neonates: Study design and ethical issues. Clinical Therapeutics 27(6):814-843.
Arnon, S. S. 2007. Creation and development of the public service orphan drug human botulism immune globulin. Pediatrics 119(4):785-789. www.cdph.ca.gov/programs/ibtpp/Documents/Peds-Creatn-Devlpmt-BIG-IV-2007.pdf (accessed March 23, 2012).
Ault, A. 2006. Liver failure warning upgraded for telithromycin. Internal Medicine News. http://www.internalmedicinenews.com/index.php?id=2049&type=98&tx_ttnews%5Btt_news%5D=11666&cHash=da03e20e36 (accessed March 23, 2012).
Ayache, S. 2009. Clinical review for Angiomax (bivalirudin). NDA 20873. September 8. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM195876.pdf (accessed March 23, 2012).
Ayalew, K. 2002. Clinical review: Use of Videx and Zerit to treat HIV infected infants and young children. NDA 20154/20155/20156/20412/20413. March 26. Silver Spring, MD: Food and Drug Administration.
Baer, G. R. 2009. Ethical issues in neonatal drug development. In Pediatric drug development: Concepts and applications, edited by A. E. Mulberg, S. A. Silber, and J. N. van den Anker. Hoboken, NJ: John Wiley & Sons, Inc. Pp. 103-114.
Baker-Smith, C. M., J. Daniel K. Benjamin, H. G. Grabowski, E. D. Reid, B. Mangum, J. V. Goldsmith, M. D. Murphy, R. Edwards, E. L. Eisenstein, J. Sun, R. M. Califf, and J. S. Li. 2008. The economic returns of pediatric clinical trials of antihypertensive drugs. American Heart Journal 156(4):682-688.
Ball, L. K. 2007. Warning letter to Gregory Irace, CEO of Sanofi-Aventis US LLC, regarding Ketek, October 23. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076552.htm (accessed March 23, 2012).
Ballentine, C. 1981. Taste of raspberries, taste of death: The 1937 elixir sulfanilamide incident. FDA Consumer, June. http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm (accessed March 23, 2012).
BARDA (Biomedical Advanced Research and Development Authority). 2011. Strategic plan 2011-2016. Washington, DC: Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services. http://www.phe.gov/about/barda/Documents/barda-strategic-plan.pdf (accessed March 23, 2012).
Barr, J., G. Brenner-Zada, E. Heiman, G. Pareth, M. Bulkowstein, R. Greenberg, and M. Berkovitch. 2002. Unlicensed and off-label medication use in a neonatal intensive care unit: A prospective study. American Journal of Perinatology 19(2):67-72.
Barron, J. J., H. Tan, J. Spalding, A. W. Bakst, and J. Singer. 2007. Proton pump inhibitor utilization patterns in infants. Journal of Pediatric Gastroenterology and Nutrition 45(4):421-427. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM214708.pdf (accessed March 23, 2012).