Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act von Avant, Debbie, Wharton, Gerold T., Murphy, Dianne

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Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy von Wharton, Gerold T, Murphy, M Dianne, Avant, Debbie, Goldsmith, John V, Chai, Grace, Rodriguez, William J, Eisenstein, Eric L

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Octreotide use and safety in infants with hyperinsulinism von McMahon, Ann W., Wharton, Gerold T., Thornton, Paul, De Leon, Diva D.

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Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals von Park, Kyunghun, Virparia, Riddhi, Green, Dionna J., Epps, Carla, Wharton, Gerold T., McCune, Susan K., Burckart, Gilbert J.

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Overview of global real‐world data sources for pediatric pharmacoepidemiologic research von Wharton, Gerold T., Becker, Claudia, Bennett, Dimitri, Burcu, Mehmet, Bushnell, Greta, Ferrajolo, Carmen, Kaplan, Sigal, McMahon, Ann W., Movva, Naimisha, Raman, Sudha R., Scholle, Oliver, Suh, Mina, Sun, Jenny W., Horton, Daniel B.

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Acute Kidney Injury During Treatment with Intravenous Acyclovir for Suspected or Confirmed Neonatal Herpes Simplex Virus Infection von Downes, Kevin J., Boge, Craig L.K., Baro, Elande, Wharton, Gerold T., Liston, Kellie M., Haltzman, Brittany L., Emerson, Hannah M., Doe, Edwin, Fulchiero, Rosanna, Tran, Van, Yen, Lilly, Lieu, Phuong, Van Driest, Sara L., Grisso, Alison G., Aka, Ida T., Hale, Jennifer, Gillon, Jessica, Pingel, Julie S., Coffin, Susan E., McMahon, Ann W.

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Pediatric post-marketing safety systems in North America: assessment of the current status von McMahon, Ann W., Wharton, Gerold T., Bonnel, Renan, DeCelle, Mary, Swank, Kimberley, Testoni, Daniela, Cope, Judith U., Smith, Phillip Brian, Wu, Eileen, Murphy, Mary Dianne

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Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review von Oshikoya, Kazeem A., Wharton, Gerold T., Avant, Debbie, Van Driest, Sara L., Fenn, Norman E., Lardieri, Allison, Doe, Edwin, Sood, Beena G., Taketomo, Carol, Lieu, Phuong, Yen, Lilly, McMahon, Ann W.

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A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013 von Egger, Gunter F., Wharton, Gerold T., Malli, Suzanne, Temeck, Jean, Murphy, M. Dianne, Tomasi, Paolo

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Pediatric post-marketing safety systems in North America: assessment of the current status: Pediatric Post-Marketing Safety Systems von McMahon, Ann W., Wharton, Gerold T., Bonnel, Renan, DeCelle, Mary, Swank, Kimberley, Testoni, Daniela, Cope, Judith U., Smith, Phillip Brian, Wu, Eileen, Murphy, Mary Dianne

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Clinician uptake of obesity-related drug information: a qualitative assessment using continuing medical education activities von Kohlstadt, Ingrid, Wharton, Gerold

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The globalization of pediatric trials: should we be worried? von Dunne, Julia, Murphy, Dianne, Wharton, Gerold

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609. Acute Kidney Injury During Treatment with Intravenous Acyclovir (AKITA) for Suspected Neonatal Herpes Simplex Virus Infection von Haltzman, Brittany L, Downes, Kevin J, Coffin, Susan E, Liston, Kellie M, Emerson, Hannah M, Doe, Edwin, Fulchiero, Rosanna, Tran, Van, Lieu, Phuong, Yen, Lilly, Driest, Sara L Van, Grisso, Alison G, Aka, Ida, Hale, Jennifer, Gillon, Jessica, Pingel, Julie, Xie, Diqiong, Wharton, Gerold, McMahon, Ann

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