{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T00:43:59Z","timestamp":1776473039734,"version":"3.51.2"},"reference-count":32,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,12,31]],"date-time":"2020-12-31T00:00:00Z","timestamp":1609372800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The scarcity of adequate pediatric drug labeling information has long been problematic in the pediatric population, which may place children at risk for adverse drug effects. The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, administration, effectiveness, and toxicity\u2010related questions that require specific investigation. Here, we review the history that led to the passage of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), and provide commentary on issues relevant to pediatric oncology now and in the future.<\/jats:p>","DOI":"10.1002\/pbc.28871","type":"journal-article","created":{"date-parts":[[2020,12,31]],"date-time":"2020-12-31T10:05:41Z","timestamp":1609409141000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority\u2014An oncology perspective"],"prefix":"10.1002","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9612-3624","authenticated-orcid":false,"given":"M. Brooke","family":"Bernhardt","sequence":"first","affiliation":[{"name":"Department of Pediatrics Division of Hematology\/Oncology Baylor College of Medicine  Houston Texas"},{"name":"Texas Children's Cancer and Hematology Centers  Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Holly","family":"Lindsay","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Hematology\/Oncology Baylor College of Medicine  Houston Texas"},{"name":"Texas Children's Cancer and Hematology Centers  Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wendy","family":"Allen\u2010Rhoades","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Hematology\/Oncology Baylor College of Medicine  Houston Texas"},{"name":"Texas Children's Cancer and Hematology Centers  Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer H.","family":"Foster","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Hematology\/Oncology Baylor College of Medicine  Houston Texas"},{"name":"Texas Children's Cancer and Hematology Centers  Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,12,31]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1937.92780500008012"},{"key":"e_1_2_7_3_1","first-page":"1106","article-title":"A study of the German outbreak of phocomelia","volume":"198","author":"Taussig HB","year":"1962","journal-title":"JAMA"},{"key":"e_1_2_7_4_1","first-page":"1332","article-title":"A study of the German outbreak of phocomelia","volume":"2","author":"Lenz W","year":"1962","journal-title":"Lancet"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM195912242612604"},{"key":"e_1_2_7_6_1","first-page":"761","article-title":"Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol","volume":"97","author":"Sutherland JM","year":"1959","journal-title":"AMA J Dis Child"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.18.4.614"},{"key":"e_1_2_7_8_1","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1542\/peds.75.3.598","article-title":"Unusual syndrome among premature infants; association with a new intravenous vitamin E product","volume":"75","author":"Lorch V","year":"1985","journal-title":"Pediatrics"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.254.17.2422"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.1982.03970470018004"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-2007-1000023"},{"key":"e_1_2_7_12_1","unstructured":"44 FR 37434 \u2013 37467"},{"issue":"12","key":"e_1_2_7_13_1","first-page":"1","article-title":"The FDA Modernization Act of 1997: impact on pediatric medicine","volume":"6","author":"Buck ML","year":"2000","journal-title":"Pediatr Pharm"},{"key":"e_1_2_7_14_1","unstructured":"US Food and Drug Administration.Federal Register.1994;59:64240\u201064250."},{"key":"e_1_2_7_15_1","unstructured":"US Food and Drug Administration.Federal Register.1998;63:66632\u201066672."},{"key":"e_1_2_7_16_1","unstructured":"Food and Drug Administration Modernization Act (FDAMA).P.L. 105\u2010115 BPCA Section 505A (21 U.S.C. 355a)."},{"key":"e_1_2_7_17_1","unstructured":"Federal Food Drug Cosmetic Act (FFDCA).Section 505B (21 U.S.C. 355c) (2003)."},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.18131"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1460-9592.2003.01071.x"},{"key":"e_1_2_7_20_1","unstructured":"Federal Food Drug Cosmetic Act (FFDCA).Section 505A (21 U.S.C. 355a) (2002)."},{"key":"e_1_2_7_21_1","unstructured":"Food and Drug Administration Safety and Innovation Act of 2012. 112 U.S.C. (2012)."},{"key":"e_1_2_7_22_1","unstructured":"US Food and Drug Administration.Federal Register.2019;84:16872\u201016874."},{"key":"e_1_2_7_23_1","unstructured":"National Institutes of Health.Prioritizing PediatricTherapies.https:\/\/www.nichd.nih.gov\/research\/supported\/bpca\/prioritizing-pediatric-therapies. Accessed May 14 2020."},{"key":"e_1_2_7_24_1","unstructured":"US Food Drug Administration.New Pediatric Labeling Information Database.https:\/\/www.accessdata.fda.gov\/scripts\/sda\/sdNavigation.cfm?sd=labelingdatabase. Accessed October 10 2020."},{"key":"e_1_2_7_25_1","unstructured":"US Food Drug Administration.Guidance for Industry: How to Comply with the Pediatric Research Equity Act. September 2005.https:\/\/www.fda.gov\/media\/86340\/download. Accessed December 3 2020."},{"key":"e_1_2_7_26_1","unstructured":"US Food Drug Administration.Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry. July 2020.https:\/\/www.fda.gov\/media\/72274\/download. Accessed December 3 2020."},{"key":"e_1_2_7_27_1","unstructured":"US Food Drug Administration.FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Guidance for Industry. December 2019.https:\/\/www.fda.gov\/media\/133440\/download. Accessed December 3 2020."},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djz207"},{"key":"e_1_2_7_29_1","unstructured":"H.R. 2430 FDA Reauthorization Act of 2017."},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30119-0"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1714448"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.28716"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(68)80414-7"}],"container-title":["Pediatric Blood &amp; Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pbc.28871","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pbc.28871","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pbc.28871","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T11:43:36Z","timestamp":1693741416000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pbc.28871"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,31]]},"references-count":32,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1002\/pbc.28871"],"URL":"https:\/\/doi.org\/10.1002\/pbc.28871","archive":["Portico"],"relation":{},"ISSN":["1545-5009","1545-5017"],"issn-type":[{"value":"1545-5009","type":"print"},{"value":"1545-5017","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,31]]},"assertion":[{"value":"2020-07-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e28871"}}