{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T15:23:49Z","timestamp":1792250629579,"version":"4.4.0"},"reference-count":8,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:p>The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has a long history advancing new approach methodologies (NAMs). In collaboration with external organizations and other regulatory agencies, FDA supports continued development of NAMs for regulatory use. Within CDER, qualification programs and interdisciplinary review teams provide opportunities for increased regulatory impact of NAMs. CDER also continues to provide regulatory input to NAMs developers and end users to advance regulatory acceptance of NAMs.<\/jats:p>","DOI":"10.1002\/cpt.70482","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T11:16:46Z","timestamp":1789730206000},"page":"1178-1180","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Advancing Regulatory Adoption of New Approach Methodologies"],"prefix":"10.1002","volume":"120","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-1984-8026","authenticated-orcid":false,"given":"Jeffry","family":"Florian","sequence":"first","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7544-0666","authenticated-orcid":false,"given":"Kimberly","family":"Chiu","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5487-5692","authenticated-orcid":false,"given":"Rebecca","family":"Racz","sequence":"additional","affiliation":[{"name":"Immediate Office, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9553-6132","authenticated-orcid":false,"given":"C. Lee","family":"Elmore","sequence":"additional","affiliation":[{"name":"Division of Pharmacology and Toxicology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9579-7457","authenticated-orcid":false,"given":"Shirley K.","family":"Seo","sequence":"additional","affiliation":[{"name":"Division of Cardiometabolic and Endocrine Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1123-3152","authenticated-orcid":false,"given":"Ksenia","family":"Blinova","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5055-4840","authenticated-orcid":false,"given":"Wendy W.","family":"Wu","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0463-9699","authenticated-orcid":false,"given":"Rodney","family":"Rouse","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,18]]},"reference":[{"key":"e_1_2_9_1_1","unstructured":"US Food and Drug Administration.New Approach Methodologies (NAMs)<https:\/\/www.fda.gov\/science\u2010research\/science\u2010and\u2010research\u2010special\u2010topics\/new\u2010approach\u2010methodologies\u2010nams>."},{"key":"e_1_2_9_2_1","unstructured":"FDA Modernization Act 2.0(2022) <https:\/\/www.congress.gov\/bill\/117th\u2010congress\/senate\u2010bill\/5002>."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.adg6228"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2025.106007"},{"key":"e_1_2_9_5_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).ICH Homepage<https:\/\/www.ich.org\/>."},{"key":"e_1_2_9_6_1","unstructured":"Animal\u2010Free Safety Assessment (AFSA) Collaboration.Workshop: Aligning Regulatory and Industry Perspectives on the Revision of ICH S7A<https:\/\/www.afsacollaboration.org\/sciencex_event\/workshop\u2010aligning\u2010regulatory\u2010and\u2010industry\u2010perspectives\u2010on\u2010the\u2010revision\u2010of\u2010ich\u2010s7a\/>."},{"key":"e_1_2_9_7_1","unstructured":"US Food and Drug Administration.Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products<https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/formal\u2010meetings\u2010between\u2010fda\u2010and\u2010sponsors\u2010or\u2010applicants\u2010pdufa\u2010products>."},{"key":"e_1_2_9_8_1","unstructured":"US Food and Drug Administration.Drug Development Tools: Fit\u2010for\u2010Purpose Initiative(2025) <https:\/\/www.fda.gov\/drugs\/development\u2010approval\u2010process\u2010drugs\/drug\u2010development\u2010tools\u2010fit\u2010purpose\u2010initiative>."}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70482","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70482","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70482","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T03:23:02Z","timestamp":1792207382000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70482"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,18]]},"references-count":8,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["10.1002\/cpt.70482"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70482","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,18]]},"assertion":[{"value":"2026-06-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-01","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-18","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}