{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T23:50:07Z","timestamp":1769730607930,"version":"3.49.0"},"reference-count":10,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T00:00:00Z","timestamp":1756166400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T00:00:00Z","timestamp":1756166400000},"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":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Optimal prescribing of drug products requires accurate informative drug labels. One critical aspect of a label is the recommended dosage. We suggest that the final authority for this portion of the label should reside in FDA's Office of Clinical Pharmacology (OCP), rather than in the Office of New Drugs, given that most FDA clinicians do not have sufficient expertise to interpret pharmacometric analyses of dose\u2010exposure, and dose\/exposure\u2010efficacy\/safety relationships.<\/jats:p>","DOI":"10.1111\/cts.70337","type":"journal-article","created":{"date-parts":[[2025,8,26]],"date-time":"2025-08-26T07:15:08Z","timestamp":1756192508000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Strengthening the Food and Drug Administration Office of Clinical Pharmacology's Labeling Authority"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0938-4392","authenticated-orcid":false,"given":"Mark J.","family":"Ratain","sequence":"first","affiliation":[{"name":"Section of Hematology\/Oncology, Department of Medicine and Committee on Clinical Pharmacology and Pharmacogenomics University of Chicago  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Garth W.","family":"Strohbehn","sequence":"additional","affiliation":[{"name":"VA Center for Clinical Management Research VA Ann Arbor  Ann Arbor Michigan USA"},{"name":"Rogel Cancer Center University of Michigan Medicine  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,8,26]]},"reference":[{"key":"e_1_2_4_2_1","unstructured":"US Food and Drug Administration \u201cGuideline for Industry. Dose\u2010Response Information to Support Drug Registration \u201d(1994 accessed December 20 2024) https:\/\/www.fda.gov\/media\/71279\/download."},{"key":"e_1_2_4_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.clpt.6100215"},{"key":"e_1_2_4_4_1","unstructured":"US Food and Drug Administration \u201cCDER. Policy and Procedures. Office of Clinical Pharmacololgy. MAPP 4000.4 Rev.1. Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) \u201d(1994 accessed April 16 2025) https:\/\/www.fda.gov\/media\/71709\/download."},{"key":"e_1_2_4_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2109826"},{"key":"e_1_2_4_6_1","unstructured":"US Food and Drug Administration \u201cCenter for Drug Evaluation and Research Application Number: 214665Orig1s000 \u201d(2020 accessed December 20 2024) https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2021\/214665Orig1s000MultidisciplineR.pdf."},{"key":"e_1_2_4_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2024.115044"},{"key":"e_1_2_4_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.24.00310"},{"key":"e_1_2_4_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0181970"},{"key":"e_1_2_4_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3611"},{"key":"e_1_2_4_11_1","unstructured":"\u201cExplanatory Statement for Agriculture Rural Development Food and Drug Administration and Related Atencies Appropriations Bill 2023 \u201d(accessed April 16 2025) https:\/\/www.appropriations.senate.gov\/imo\/media\/doc\/AGFY23RPT.PDF."}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70337","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.70337","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70337","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T11:39:23Z","timestamp":1769686763000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70337"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,26]]},"references-count":10,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1111\/cts.70337"],"URL":"https:\/\/doi.org\/10.1111\/cts.70337","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,26]]},"assertion":[{"value":"2025-04-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70337"}}