{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T21:05:19Z","timestamp":1782939919387,"version":"3.54.5"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T00:00:00Z","timestamp":1754352000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T00:00:00Z","timestamp":1754352000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["HHS75F40121C00188"],"award-info":[{"award-number":["HHS75F40121C00188"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2025,12]]},"DOI":"10.1007\/s40264-025-01581-2","type":"journal-article","created":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T09:24:20Z","timestamp":1754385860000},"page":"1387-1397","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies"],"prefix":"10.1007","volume":"48","author":[{"given":"Celeste L. Y.","family":"Ewig","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanning","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole E.","family":"Smolinski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gita A.","family":"Toyserkani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"LaCivita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leila","family":"Lackey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Eggers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leyla","family":"Sahin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reem S.","family":"Abu-Rustum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian T.","family":"Bateman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anick","family":"Berard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina D.","family":"Chambers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth","family":"Choby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Conover","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael F.","family":"Greene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Hern\u00e1ndez-D\u00edaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise J.","family":"Jamieson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah G.","family":"Obi\u010dan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janine E.","family":"Polifka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kay","family":"Roussos-Ross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanne S.","family":"Sheffield","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon Voyer","family":"Lavigne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen M.","family":"Zimmermann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan B.","family":"Laffan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony M.","family":"DeLise","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia W.","family":"Gilsenan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarek A.","family":"Hammad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Hampp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet R.","family":"Hardy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin A.","family":"Knox","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristine","family":"Shields","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meredith Y.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel E.","family":"Sobel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa S.","family":"Tassinari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith C.","family":"Maro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonja A.","family":"Rasmussen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6518-5961","authenticated-orcid":false,"given":"Almut G.","family":"Winterstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,8,5]]},"reference":[{"key":"1581_CR1","unstructured":"US Food and Drug Administration (FDA). Risk evaluation and mitigation strategies (REMS) 2023. https:\/\/www.fda.gov\/drugs\/our-perspective\/risk-evaluation-and-mitigation-strategies-rems. Accessed 25 June 2025."},{"issue":"1","key":"1581_CR2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.44386","volume":"5","author":"A Sarpatwari","year":"2022","unstructured":"Sarpatwari A, Brown BL, McGraw SA, Dejene SZ, Abdurrob A, Santiago Ortiz AJ, et al. Patient and caregiver experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use. JAMA Netw Open. 2022;5(1): e2144386.","journal-title":"JAMA Netw Open"},{"issue":"7","key":"1581_CR3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0288008","volume":"18","author":"A Sarpatwari","year":"2023","unstructured":"Sarpatwari A, Brown BL, McGraw SA, Dejene SZ, Abdurrob A, Kesselheim AS. Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use. PLoS ONE. 2023;18(7): e0288008.","journal-title":"PLoS ONE"},{"issue":"6","key":"1581_CR4","doi-asserted-by":"publisher","first-page":"1293","DOI":"10.1002\/cpt.3189","volume":"115","author":"A Sarpatwari","year":"2024","unstructured":"Sarpatwari A, Lu Z, Russo M, Zakoul H, Lee SB, Toyserkani GA, et al. How do risk evaluation and mitigation strategies impact clinical practice? A national survey of physicians. Clin Pharmacol Ther. 2024;115(6):1293\u2013303.","journal-title":"Clin Pharmacol Ther"},{"key":"1581_CR5","unstructured":"US Food and Drug Administration (FDA). Risk evaluation and mitigation strategy (REMS) public dashboard 2024. https:\/\/www.fda.gov\/drugs\/risk-evaluation-and-mitigation-strategies-rems\/risk-evaluation-and-mitigation-strategy-rems-public-dashboard. Accessed 25 June 2025."},{"key":"1581_CR6","unstructured":"Management of drug-related teratogenic risk: day 1. FDA Background Package for Meeting of the Drug Safety and Risk\u00a0Management\u00a0Advisory Committee (DSaRM), Silver Spring, MD: Food and Drug Administration; 2012. https:\/\/wayback.archive-it.org\/7993\/20170405214305\/https:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/Drugs\/DrugSafetyandRiskManagementAdvisoryCommittee\/UCM331163.pdf. Accessed 25 June 2025."},{"issue":"1","key":"1581_CR7","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajogmf.2023.101245","volume":"6","author":"Y Wang","year":"2024","unstructured":"Wang Y, Smolinski NE, Thai TN, Sarayani A, Ewig C, Rasmussen SA, et al. Common teratogenic medication exposures: a population-based study of pregnancies in the United States. Am J Obstet Gynecol MFM. 2024;6(1): 101245.","journal-title":"Am J Obstet Gynecol MFM."},{"key":"1581_CR8","unstructured":"Summary Minutes of the Drug Safety and Risk Management Advisory Committee Meeting Silver Spring, MD: Food and Drug Administration; 2012. https:\/\/wayback.archive-it.org\/7993\/20170404151304\/https:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/Drugs\/DrugSafetyandRiskManagementAdvisoryCommittee\/UCM343814.pdf. Accessed 25 June 2025."},{"issue":"2","key":"1581_CR9","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1007\/s40264-024-01488-4","volume":"48","author":"AG Winterstein","year":"2025","unstructured":"Winterstein AG, Ewig CLY, Wang Y, Smolinski NE, Toyserkani GA, LaCivita C, et al. Teratogenic Risk Impact and Mitigation (TRIM): study protocol for the development of a decision support tool to prioritize medications for risk mitigation. Drug Saf. 2025;48(2):107\u201317.","journal-title":"Drug Saf"},{"issue":"3","key":"1581_CR10","doi-asserted-by":"publisher","first-page":"458","DOI":"10.1287\/mnsc.9.3.458","volume":"9","author":"N Dalkey","year":"1963","unstructured":"Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Manag Sci. 1963;9(3):458\u201367.","journal-title":"Manag Sci"},{"key":"1581_CR11","doi-asserted-by":"crossref","unstructured":"Murphy MK, Black NA, Lamping DL, McKee CM, Sanderson CF, Askham J, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess. 1998;2(3):i\u2013iv, 1\u201388.","DOI":"10.3310\/hta2030"},{"issue":"9","key":"1581_CR12","doi-asserted-by":"publisher","first-page":"986","DOI":"10.1002\/pds.3480","volume":"22","author":"BA Briesacher","year":"2013","unstructured":"Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, et al. A critical review of methods to evaluate the impact of FDA regulatory actions. Pharmacoepidemiol Drug Saf. 2013;22(9):986\u201394.","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"6","key":"1581_CR13","doi-asserted-by":"publisher","first-page":"575","DOI":"10.1007\/s40264-024-01421-9","volume":"47","author":"M Fusaroli","year":"2024","unstructured":"Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, et al. The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV): development and statement. Drug Saf. 2024;47(6):575\u201384.","journal-title":"Drug Saf"},{"key":"1581_CR14","doi-asserted-by":"publisher","DOI":"10.4135\/9781412984287","volume-title":"Focus groups as qualitative research","author":"DL Morgan","year":"1997","unstructured":"Morgan DL. Focus groups as qualitative research. 1st ed. Thousand Oaks: SAGE Publications, Inc.; 1997.","edition":"1"},{"issue":"6","key":"1581_CR15","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1038\/bdj.2008.192","volume":"204","author":"P Gill","year":"2008","unstructured":"Gill P, Stewart K, Treasure E, Chadwick B. Methods of data collection in qualitative research: interviews and focus groups. Br Dent J. 2008;204(6):291\u20135.","journal-title":"Br Dent J"},{"issue":"3","key":"1581_CR16","doi-asserted-by":"publisher","first-page":"1286","DOI":"10.1038\/s41380-021-01381-x","volume":"27","author":"L Sforzini","year":"2022","unstructured":"Sforzini L, Worrell C, Kose M, Anderson IM, Aouizerate B, Arolt V, et al. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Mol Psychiatry. 2022;27(3):1286\u201399.","journal-title":"Mol Psychiatry"},{"key":"1581_CR17","unstructured":"US Food and Drug Administration (FDA). REMS: FDA's application of statutory factors in determining when a REMS is necessary: guidance for industry. 2019. https:\/\/www.fda.gov\/media\/100307\/download. Accessed 25 June 2025."},{"issue":"4","key":"1581_CR18","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1016\/j.jval.2010.11.013","volume":"14","author":"JF Bridges","year":"2011","unstructured":"Bridges JF, Hauber AB, Marshall D, Lloyd A, Prosser LA, Regier DA, et al. Conjoint analysis applications in health\u2014a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force. Value Health. 2011;14(4):403\u201313.","journal-title":"Value Health."},{"issue":"4","key":"1581_CR19","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1016\/j.jclinepi.2013.12.002","volume":"67","author":"IR Diamond","year":"2014","unstructured":"Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401\u20139.","journal-title":"J Clin Epidemiol"},{"key":"1581_CR20","unstructured":"European Medicines Agency. Guideline on good pharmacovigilance practices (GVP),\u00a0Module XVI: risk minimisation measures (Rev 3).\u00a02024. https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-xvi-risk-minimisation-measures-rev-3_en.pdf. Accessed 25 June 2025."},{"key":"1581_CR21","unstructured":"European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP). 2017. https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/good-pharmacovigilance-practices-gvp. Accessed 25 June 2025."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-025-01581-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-025-01581-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-025-01581-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T05:19:53Z","timestamp":1762838393000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-025-01581-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,5]]},"references-count":21,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["1581"],"URL":"https:\/\/doi.org\/10.1007\/s40264-025-01581-2","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,5]]},"assertion":[{"value":"18 June 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 August 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was funded by contract HHS75F40121C00188 with the US FDA. Expert panelist volunteered their time and were not compensated for the participation. The views in this article are those of the authors and not necessarily those of the FDA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Cynthia LaCivita was formerly with the Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA. She is currently a consultant to Glaxo Smith Kline, United BioSource, and Stallergenes. Anick Berard is the holder of a Canada Research Chair, and a Louis Boivin Family Research Chair on Medications and Pregnancy. The Centers for Disease Control and Prevention receives research funding from the following industry sponsors and a foundation: Amgen, AstraZeneca, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer, Inc., Regeneron, Hoffman La-Roche-Genentech, Genzyme Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Sanofi, UCB Pharma, USA, Leo Pharma, Sun Pharma Global FZE, Gilead, Novartis, and the Gerber Foundation. Sonia Hern\u00e1ndez-D\u00edaz consulted for Roche and Moderna; participated as an investigator in projects funded by Takeda and UCB; and was an advisor for the Antiepileptic and the Antipsychotics Pregnancy Registries, which are funded by multiple companies. Sarah G. Obi\u010dan has served in the last 2 years as an expert witness working in acetaminophen litigation and polychlorinated biphenyls.\u00a0Christian Hampp is an employee and shareholder of Regeneron. Caitlin A. Knox is an employee and shareholder of Regeneron and a shareholder of Vertex Pharmaceuticals. Meredith Y. Smith is a shareholder in Thermo Fisher Scientific, Amgen, AbbVie, Abbott, and Eli Lilly. Rachel E. Sobel is an employee and shareholder of Regeneron and a shareholder of Pfizer Inc. Sonja A. Rasmussen serves on scientific advisory committees for several pregnancy registries, including registries for Harmony, Axsome, and Biohaven, recently acquired by Pfizer, Novo Nordisk, and Myovant Sciences. Almut G. Winterstein has received research funding from Merck and has served as a consultant for Merck, Bayer KG, Ipsen, Lykos, Syneos, and Novo Nordisk. Almut G. Winterstein is an Editorial Board member of\n                      Drug Safety\n                      . Almut G. Winterstein was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. Nicole E. Smolinski owns stock through inheritance in Baxter, Cardinal Health, CVS Health, Edwards LifeSciences, and Takeda unrelated to this work. All other authors have no conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/competing interests"}},{"value":"This study was approved by the University of Florida Institutional Review Board (IRB202102721). Participants were informed that their participation in the study implied consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All expert panel members provided consent for their participation in this study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors (1) made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; (2) drafted of the work or reviewed it critically for important intellectual content; (3) gave final approval of the version to be published; and (4)\u00a0agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}