{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T18:49:04Z","timestamp":1784832544216,"version":"3.55.0"},"reference-count":9,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2019,7,1]],"date-time":"2019-07-01T00:00:00Z","timestamp":1561939200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2019,7]]},"DOI":"10.1177\/2168479018791560","type":"journal-article","created":{"date-parts":[[2018,9,17]],"date-time":"2018-09-17T05:10:37Z","timestamp":1537161037000},"page":"542-548","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Managing the Risks of Medicines: An Examination of FDA\u2019s Application of Criteria for Requiring a REMS"],"prefix":"10.1007","volume":"53","author":[{"given":"Paul J.","family":"Seligman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebekah H.","family":"Anguiano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Felix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Stabi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,12,23]]},"reference":[{"key":"5304542_CR1","unstructured":"Public Law 110-85. Food and Drug Administration Amendments Act (FDAAA) of 2007. Title IX, Subtitle A, Section 505-1. Enhanced Authorities Regarding Postmarket Safety of Drugs, Risk Evaluation and Mitigation Strategies. https:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-110publ85\/pdf\/PLAW-110publ85.pdf. Published September 27, 2007."},{"issue":"6","key":"5304542_CR2","doi-asserted-by":"publisher","first-page":"724","DOI":"10.1177\/2168479014527749","volume":"48","author":"M Cronin","year":"2014","unstructured":"Cronin M, Berger S, Seligman P. Risk evaluation and mitigation strategies with elements to assure safe use\u2014alignment of the goals with the tools to manage risk. Therapeutic Innovation & Regulatory Science. 2014;48(6):724\u2013733.","journal-title":"Therapeutic Innovation & Regulatory Science"},{"key":"5304542_CR3","unstructured":"US Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). https:\/\/www.accessdata.fda.gov\/scripts\/cder\/rems\/index.cfm."},{"key":"5304542_CR4","unstructured":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. FDA\u2019s Application of Statutory Factors in Determining When a REMS Is Necessary\u2014Guidance for Industry. https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM521504.pdf. Published September 2016."},{"key":"5304542_CR5","unstructured":"US Food and Drug Administration, Center for Drug Evaluation and Research. Advancing Health through Innovation\u20142017 New Drug Therapy Approvals. https:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDER\/ReportsBudgets\/UCM591976.pdf. Published January 2018."},{"key":"5304542_CR6","unstructured":"US Food and Drug Administration, Center for Drug Evaluation and Research. 2016 Novel Drugs Summary. https:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DrugInnovation\/UCM536693.pdf. Published January 2017."},{"key":"5304542_CR7","unstructured":"US Food & Drug Administration. Center for Drug Evaluation and Research. 2015 Novel Drugs Summary. https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DrugInnovation\/ucm474696.htm. Published January 2016."},{"issue":"17","key":"5304542_CR8","doi-asserted-by":"publisher","first-page":"1793","DOI":"10.1001\/jama.2015.11871","volume":"314","author":"MY Smith","year":"2015","unstructured":"Smith MY, Seligman PJ. New opportunities for integrating drug safety risk management programs into the health care system\u2014bridging the divide. JAMA. 2015;314(17):1793\u20131794.","journal-title":"JAMA"},{"key":"5304542_CR9","unstructured":"US Department of Health and Human Services, Food and Drug Administration. Managing the risks from medical product use\u2014creating a risk management framework. A Report to the FDA Commissioner from the Task Force on Risk Management. May 1999."}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1177\/2168479018791560.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2168479018791560","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1177\/2168479018791560\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2168479018791560","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1177\/2168479018791560.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,8,21]],"date-time":"2020-08-21T13:17:55Z","timestamp":1598015875000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1177\/2168479018791560"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7]]},"references-count":9,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019,7]]}},"alternative-id":["5304542"],"URL":"https:\/\/doi.org\/10.1177\/2168479018791560","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7]]},"assertion":[{"value":"2 May 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 July 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}]}}