{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T18:28:13Z","timestamp":1786991293368,"version":"build-2736575974"},"reference-count":21,"publisher":"BMJ","license":[{"start":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T00:00:00Z","timestamp":1786406400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.bmj.com\/company\/legal-information\/terms-conditions\/legal-information\/tdm-licencepolicy"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"DOI":"10.1136\/bmj-2026-100438","type":"journal-article","created":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T11:20:10Z","timestamp":1786447210000},"page":"e100438","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Pitfalls of announcing regulatory policy in medical journals"],"prefix":"10.1136","volume":"394","author":[{"given":"S Sean","family":"Tu","sequence":"first","affiliation":[{"name":"University of Alabama School of Law, Tuscaloosa, AL, USA"},{"name":"Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron S","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital, Boston, MA, USA"},{"name":"Harvard Medical School, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,8,11]]},"reference":[{"key":"2026081710550839000_394.aug11_7.e100438.1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb2506929"},{"key":"2026081710550839000_394.aug11_7.e100438.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb2512695"},{"key":"2026081710550839000_394.aug11_7.e100438.3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.22259"},{"key":"2026081710550839000_394.aug11_7.e100438.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb2517623"},{"key":"2026081710550839000_394.aug11_7.e100438.5","unstructured":"FDA Matters. Dr. Pazdur\u2019s new role at CDER: more than just adding stable leadership. FDA Matters 19 Nov 2025. https:\/\/www.fdamatters.com\/dr-pazdurs-new-role-at-cder\/"},{"key":"2026081710550839000_394.aug11_7.e100438.6","unstructured":"FDA acting chief walks back Makary\u2019s practice of policymaking through journals. Endpoints News. 15 Jul 2026. https:\/\/endpoints.news\/fda-acting-chief-walks-back-makarys-practice-of-policymaking-through-journals\/"},{"key":"2026081710550839000_394.aug11_7.e100438.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(26)00600-8"},{"key":"2026081710550839000_394.aug11_7.e100438.8","unstructured":"Speaker rebukes Reeves for budget comments in US. BBC News. 29 Oct 2024. https:\/\/www.bbc.com\/news\/articles\/c80lvy3lnn1o"},{"key":"2026081710550839000_394.aug11_7.e100438.9","unstructured":"Code of Federal Regulations. Good guidance practices. 21 CFR 10.115(e). https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-10\/subpart-B\/section-10.115."},{"key":"2026081710550839000_394.aug11_7.e100438.10","unstructured":"Lynch HF, Ramachandran R, Sachs R, Joffe S, Zettler P. The promise and perils of FDA\u2019s new \u2018plausible mechanism\u2019 pathway (Part 2). Health Affairs Forefront 23 Jan 2026. https:\/\/www.healthaffairs.org\/content\/forefront\/promise-and-perils-fda-s-new-plausible-mechanism-pathway-part-2"},{"key":"2026081710550839000_394.aug11_7.e100438.11","unstructured":"ICAEW Principles of good regulation. 2023. https:\/\/www.icaew.com\/technical\/trust-and-ethics\/better-regulation\/better-regulation-briefing\/1-principles-of-good-regulation"},{"key":"2026081710550839000_394.aug11_7.e100438.12","unstructured":"European Medicines Agency. Procedure for European Union Guidelines and related documents within the pharmaceutical legislative framework. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/procedure-european-union-guidelines-and-related-documents-within-pharmaceutical-legislative-framework_en.pdf."},{"key":"2026081710550839000_394.aug11_7.e100438.13","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.9898"},{"key":"2026081710550839000_394.aug11_7.e100438.14","unstructured":"Letters to the editor. [Responses to Prasad V, Makary MA. An evidence-based approach to covid-19 vaccination. N Eng J Med 2025.] https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMc2507760."},{"key":"2026081710550839000_394.aug11_7.e100438.15","unstructured":"Lynch HF, Ramachandran R, Sachs R, Joffe S, Zettler P. The promise and perils of fda\u2019s new \u2018plausible mechanism\u2019 pathway (part 2). Health Affairs Forefront January 23, 2026. https:\/\/www.healthaffairs.org\/content\/forefront\/promise-and-perils-fda-s-new-plausible-mechanism-pathway-part-2"},{"key":"2026081710550839000_394.aug11_7.e100438.16","unstructured":"FDA approves fall Covid shots, but with new restrictions. NBC News. 28 Aug 2025. https:\/\/www.nbcnews.com\/health\/health-news\/fda-approves-fall-covid-shots-new-restrictions-rfk-jr-rcna227569"},{"key":"2026081710550839000_394.aug11_7.e100438.17","unstructured":"A stricter FDA policy for COVID vaccines could limit future access. NPR. 2025. https:\/\/www.npr.org\/sections\/shots-health-news\/2025\/05\/20\/nx-s1-5405013\/fda-covid-vaccine-limits"},{"key":"2026081710550839000_394.aug11_7.e100438.18","unstructured":"The latest COVID vaccines come with new FDA limits. NPR. 27 Aug 2025. https:\/\/www.npr.org\/sections\/shots-health-news\/2025\/08\/27\/nx-s1-5515503\/fda-covid-vaccines-restricted"},{"key":"2026081710550839000_394.aug11_7.e100438.19","unstructured":"Pediatricians win Round 1 in vaccine fight, but damage has been done. Reuters. 17 Mar 2026. https:\/\/www.reuters.com\/legal\/litigation\/pediatricians-win-round-1-vaccine-fight-damage-has-been-done-2026-03-17\/"},{"key":"2026081710550839000_394.aug11_7.e100438.20","unstructured":"Fox News. Dr Marty Makary responds to critiques from former top FDA vaccine official over direction of agency. The Megyn Kelly Show. 21 Apr 2025. https:\/\/www.youtube.com\/watch?app=desktop&v=-ZKkXlFR8FQ"},{"key":"2026081710550839000_394.aug11_7.e100438.21","unstructured":"FDA. Considerations for the use of the plausible mechanism framework to develop individualized therapies that target specific genetic conditions with known biological cause; draft guidance for industry. 2026. https:\/\/www.regulations.gov\/document\/FDA-2026-D-1256-0002\/comment"}],"container-title":["BMJ"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/data.bmj.org\/tdm\/10.1136\/bmj-2026-100438","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmj-2026-100438","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T17:55:13Z","timestamp":1786989313000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj-2026-100438"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,11]]},"references-count":21,"alternative-id":["10.1136\/bmj-2026-100438"],"URL":"https:\/\/doi.org\/10.1136\/bmj-2026-100438","relation":{},"ISSN":["1756-1833"],"issn-type":[{"value":"1756-1833","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,11]]}}}