{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T10:30:49Z","timestamp":1669804249406},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JOP"],"published-print":{"date-parts":[[2012,11]]},"abstract":"<jats:p> The authors reviewed FDA and manufacturer responses to a citizen petition filed to address thalidomide safety issues and concluded that new approaches addressing off-label safety are needed. <\/jats:p>","DOI":"10.1200\/jop.2011.000504","type":"journal-article","created":{"date-parts":[[2012,11,16]],"date-time":"2012-11-16T23:29:15Z","timestamp":1353108555000},"page":"e158-e167","source":"Crossref","is-referenced-by-count":2,"title":["A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions\u2014A SONAR Report"],"prefix":"10.1200","volume":"8","author":[{"given":"Brian","family":"Chen","sequence":"first","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Restaino","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"LeAnn","family":"Norris","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sudha","family":"Xirasagar","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zaina P.","family":"Qureshi","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"June M.","family":"McKoy","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isaac S.","family":"Lopez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alyssa","family":"Trenery","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alanna","family":"Murday","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Kahn","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald R.","family":"Mattison","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Ray","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver","family":"Sartor","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles L.","family":"Bennett","sequence":"additional","affiliation":[{"name":"University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp068228"},{"key":"B4","unstructured":"DP Carpenter:  Reputation and the organizational politics of new drug review, in Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA 2010 Princeton, NJ Princeton University Press"},{"key":"B5","volume-title":"Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation","author":"Hilts P","year":"2003"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(61)90927-8"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1002\/cpt196563303"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(00)88289-2"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629040-00003"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199911183412102"},{"key":"B11","doi-asserted-by":"crossref","DOI":"10.1182\/blood.V104.11.265.265","volume":"104","author":"Evens A","year":"2004","journal-title":"Blood"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.10847"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V98.5.1614"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.21.2558-c"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.1853"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2405062"},{"key":"B30","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djr062"},{"key":"B33","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200106213442516"},{"key":"B34","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(02)01300-1"},{"key":"B36","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V98.2.492"},{"key":"B37","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200124020-00002"},{"key":"B40","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.17.2215"},{"key":"B42","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc053530"},{"key":"B43","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.2201"},{"key":"B45","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.1283"},{"key":"B47","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa0706341"}],"container-title":["Journal of Oncology Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JOP.2011.000504","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,26]],"date-time":"2022-05-26T00:34:17Z","timestamp":1653525257000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JOP.2011.000504"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,11]]},"references-count":24,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2012,11]]}},"alternative-id":["10.1200\/JOP.2011.000504"],"URL":"https:\/\/doi.org\/10.1200\/jop.2011.000504","relation":{},"ISSN":["1554-7477","1935-469X"],"issn-type":[{"value":"1554-7477","type":"print"},{"value":"1935-469X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,11]]}}}