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Ethics"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The US Food and Drug Administration (FDA) has historically exercised substantial regulatory flexibility to adjust the type, amount, and quality of evidence necessary to support drug approval for areas of unmet need. Our objective was to characterize how FDA officials described and justified regulatory flexibility in recent public statements. We conducted a thematic analysis of quotations related to regulatory flexibility from 31 FDA officials published in Pink Sheet and STAT, two leading news sources covering FDA, from January 2021 to June 2024. In these statements, FDA officials typically justified prioritizing patient access to promising treatments over certainty regarding efficacy at the time of approval, even outside the accelerated approval pathway. Regulators also highlighted confirmatory studies conducted after accelerated approval as important for establishing drug efficacy. However, they recognized challenges to their completion, including insufficient industry incentives and FDA enforcement, and were reticent to interpret failed studies as evidence of failed drugs. Overall, in public statements from 2021\u20132024, FDA officials acknowledged challenges posed by regulatory flexibility but publicly justified its broad use to improve patient access for serious diseases despite even extended uncertainty. Under the Trump Administration, many officials have changed but efforts to advance regulatory flexibility continue.<\/jats:p>","DOI":"10.1017\/jme.2026.10290","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:05:35Z","timestamp":1790917535000},"page":"1-11","source":"Crossref","is-referenced-by-count":0,"title":["US Food and Drug Administration Officials\u2019 Public Statements on Regulatory Flexibility in New Drug Approval, 2021\u20132024"],"prefix":"10.1017","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1943-0962","authenticated-orcid":false,"given":"Tiffany E.","family":"Jiang","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03v76x132","id-type":"ROR","asserted-by":"publisher"}],"name":"Yale School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia S.","family":"Etkin","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03vek6s52","id-type":"ROR","asserted-by":"publisher"}],"name":"Harvard Medical School"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kennedy","family":"Caldwell","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00b30xv10","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Pennsylvania Perelman School of Medicine"},{"name":"University of Pennsylvania Carey School of Law"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Zhang","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00b30xv10","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sejin","family":"Lee","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00b30xv10","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Pennsylvania Perelman School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03v76x132","id-type":"ROR","asserted-by":"publisher"}],"name":"Yale School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3845-3606","authenticated-orcid":false,"given":"Reshma","family":"Ramachandran","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03v76x132","id-type":"ROR","asserted-by":"publisher"}],"name":"Yale School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly Fernandez","family":"Lynch","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/00b30xv10","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Pennsylvania Perelman School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,10,2]]},"reference":[{"key":"S1073110526102903_r26","unstructured":"26. Lynch and Sachs, \u201cPreapproval Promises to Voluntarily Withdraw.\u201d"},{"key":"S1073110526102903_r57","unstructured":"57. FDA Office of the Commissioner, \u201cFDA Takes Action to Make a Treatment Available for Autism Symptoms,\u201d news release, September 22, 2025, https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-action-make-treatment-available-autism-symptoms."},{"key":"S1073110526102903_r14","doi-asserted-by":"publisher","DOI":"10.1093\/haschl\/qxaf183"},{"key":"S1073110526102903_r58","unstructured":"58. FDA Office of the Commissioner, \u201cFDA Takes Action to Make a Treatment Available\u201d; Claire Cameron, \u201cFDA Declines to Approve Drug Touted by Trump as a Treatment for Autism,\u201d Scientific American, March 11, 2026, https:\/\/www.scientificamerican.com\/article\/the-fda-approves-leucovorin-for-rare-genetic-condition-and-not-for-autism\/ (last visited May 13, 2026)."},{"key":"S1073110526102903_r27","unstructured":"27. Karlin-Smith, Sarah , \u201cTolerating False Positives: Amylyx, FDA, and the Legal Case for Broad Regulatory Flexibility,\u201d Insights, September 8, 2022, https:\/\/insights.citeline.com\/PS146975\/Tolerating-False-Positives-Amylyx-FDA-And-The-Legal-Case-For-Broad-Regulatory-Flexibility\/."},{"key":"S1073110526102903_r29","unstructured":"29. Sandburg, Brenda , \u201cFDA On What Aduhelm AdCom Got Wrong: Statistics, Investigational Drugs, Patient Perspective,\u201d Pink Sheet Insights, June 29, 2021, https:\/\/insights.citeline.com\/PS144558\/FDA-On-What-Aduhelm-AdCom-Got-Wrong-Statistics-Investigational-Drugs-Patient-Perspective\/."},{"key":"S1073110526102903_r30","unstructured":"30. \u201cDrug Approval Package: Aduhelm (Aducanumab-Avwa),\u201d https:\/\/web.archive.org\/web\/20251214211455\/https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2021\/761178Orig1s000TOC.cfm (last visited December 20, 2025)."},{"key":"S1073110526102903_r22","unstructured":"22. Sutter, Sue , \u201cAccelerated Approval Withdrawals: Will Non-Oncology Indications Stop \u2018Dangling\u2019 In 2024?,\u201d Pink Sheet Insights, January 30, 2024, https:\/\/insights.citeline.com\/PS149668\/Accelerated-Approval-Withdrawals-Will-Non-Oncology-Indications-Stop-Dangling-In-2024\/."},{"key":"S1073110526102903_r41","unstructured":"41. Gingery, Derrick , \u201cIs Sarepta\u2019s Gene Therapy Elevidys Casting Doubt on a Popular DMD Endpoint?,\u201d Pink Sheet Insights, January 17, 2024, https:\/\/insights.citeline.com\/PS149606\/Is-Sareptas-Gene-Therapy-Elevidys-Casting-Doubt-On-A-Popular-DMD-Endpoint\/."},{"key":"S1073110526102903_r16","unstructured":"16. \u201cPink Sheet,\u201d Citeline, https:\/\/www.citeline.com\/en\/products-services\/regulatory-and-compliance\/pink-sheet (last accessed December 20, 2025)."},{"key":"S1073110526102903_r9","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.5613"},{"key":"S1073110526102903_r21","unstructured":"21. Owermohle, Sarah , \u201cFDA\u2019s Woodcock Reflects on More Than 30 Years at Agency \u2014 and Hints at What\u2019s Next,\u201d STAT, January 30, 2024, https:\/\/www.statnews.com\/2024\/01\/30\/janet-woodcock-fda-next-chapter\/."},{"key":"S1073110526102903_r19","unstructured":"19. Gingery, Derrick , \u201cUS FDA\u2019s Marks Willing to Accept Gene Therapies Occasionally Not Confirming Benefit,\u201d Pink Sheet Insights, December 5, 2023, https:\/\/web.insights.norstella-labs.com\/PS149454\/US-FDAs-Marks-Willing-To-Accept-Gene-Therapies-Occasionally-Not-Confirming-Benefit\/."},{"key":"S1073110526102903_r64","unstructured":"64. Jewett, Christina , \u201cF.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure,\u201d New York Times, May 12, 2026, https:\/\/www.nytimes.com\/2026\/05\/12\/us\/politics\/trump-fires-fda-commissioner-makary.html."},{"key":"S1073110526102903_r13","unstructured":"13. The Editorial Board, \u201cMarty Makary\u2019s Fatal Mistakes,\u201d Opinion, Wall Street Journal, May 8, 2026, https:\/\/www.wsj.com\/opinion\/marty-makary-fda-donald-trump-drug-approvals-c46f1518; The Editorial Board, \u201cAnother Marty Makary Mistake,\u201d Opinion, Wall Street Journal, May 5, 2026, https:\/\/www.wsj.com\/opinion\/marty-makary-vinay-prasad-katherine-szarama-fda-2f70e24d."},{"key":"S1073110526102903_r23","unstructured":"23. Gingery, Derrick , \u201cCaliff Says Accelerated Approval a \u2018Different Objective\u2019 and \u2018Lower Hurdle,\u2019\u201d Pink Sheet Insights, April 1, 2022, https:\/\/insights.citeline.com\/PS145961\/Califf-Says-Accelerated-Approval-A-Different-Objective-And-Lower-Hurdle\/."},{"key":"S1073110526102903_r40","unstructured":"40. Sutter, \u201cGene Therapy.\u201d"},{"key":"S1073110526102903_r8","unstructured":"8. \u201cAmylyx Pharmaceuticals Announces Formal Intention to Remove RELYVRIO\u00ae\/ALBRIOZATM from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy,\u201d Amylyx, April 4, 2024, https:\/\/www.amylyx.com\/news\/amylyx-pharmaceuticals-announces-formal-intention-to-remove-relyvrior\/albriozatm-from-the-market-provides-updates-on-access-to-therapy-pipeline-corporate-restructuring-and-strategy; \u201cAmylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Suspension, 3 Gram\/Packet and 1 Gram\/Packet,\u201d Federal Register, August 29, 2025, https:\/\/www.federalregister.gov\/documents\/2025\/08\/29\/2025-16646\/amylyx-pharmaceuticals-inc-withdrawal-of-approval-of-new-drug-application-for-relyvrio-sodium."},{"key":"S1073110526102903_r31","unstructured":"31. Gingery, Derrick , \u201cAccelerated Approval Now Starting Point for Gene Therapy Development, US FDA\u2019s Marks Says,\u201d Pink Sheet Insights, February 28, 2024, https:\/\/insights.citeline.com\/PS149861\/Accelerated-Approval-Now-Starting-Point-For-Gene-Therapy-Development-US-FDAs-Marks-Says\/."},{"key":"S1073110526102903_r43","unstructured":"43. Sutter, Sue , \u201cConfirmatory Trials: Flexibility in Timing Hinges on Accelerated Approval Indication Size \u2013 FDA\u2019s Marks,\u201d Pink Sheet Insights, January 29, 2024, https:\/\/insights.citeline.com\/PS149685\/Confirmatory-Trials-Flexibility-In-Timing-Hinges-On-Accelerated-Approval-Indication-Size--FDAs-Marks\/."},{"key":"S1073110526102903_r53","unstructured":"53. Lynch et al., \u201cExtending the US Food and Drug Administration\u2019s Postmarket Authorities.\u201d"},{"key":"S1073110526102903_r56","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.24532"},{"key":"S1073110526102903_r24","unstructured":"24. Owermohle, \u201cFDA\u2019s Woodcock Reflects.\u201d"},{"key":"#cr-split#-S1073110526102903_r60.1","unstructured":"60. Christina Jewett, \"F.D.A. Faces Upset Over Denials of New Drugs,\" New York Times, March 5, 2026, https:\/\/www.nytimes.com\/2026\/03\/05\/health\/fda-drugs-rare-diseases-rfk-jr.html"},{"key":"#cr-split#-S1073110526102903_r60.2","unstructured":"Angelica Peebles, \"FDA Reversals Leave Investors Worrying About the Fates of Other Experimental Drugs,\" CNBC, March 6, 2026, https:\/\/www.cnbc.com\/2026\/03\/06\/fda-reversals-on-uniqure-moderna-approvals-worry-investors.html."},{"key":"S1073110526102903_r6","unstructured":"6. \u201cBiogen to Realign Resources for Alzheimer\u2019s Disease Franchise,\u201d Biogen, January 31, 2024, https:\/\/investors.biogen.com\/news-releases\/news-release-details\/biogen-realign-resources-alzheimers-disease-franchise (last visited December 20, 2025)."},{"key":"S1073110526102903_r15","unstructured":"15. Lynch et al., \u201cFlexibility Over Rigor.\u201d"},{"key":"S1073110526102903_r45","unstructured":"45. Rawson, \u201cUnger Unplugged.\u201d"},{"key":"S1073110526102903_r12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb2512695"},{"key":"S1073110526102903_r7","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.22566"},{"key":"S1073110526102903_r10","unstructured":"10. \u201cCommunity Letter: Update Regarding ELEVIDYS,\u201d Sarepta Therapeutics, July 19, 2025, https:\/\/www.sarepta.com\/community-letter-update-regarding-elevidys (last visited December 20, 2025)."},{"key":"S1073110526102903_r37","unstructured":"37. Baghdadi, Ramsey , \u201cAccelerated Approval for Gene Therapies: FDA\u2019s Wilson Bryan Offers a \u2018Framework,\u2019\u201d Pink Sheet Insights, October 27, 2022, https:\/\/insights.citeline.com\/PS147230\/Accelerated-Approval-For-Gene-Therapies-FDAs-Wilson-Bryan-Offers-A-Framework\/."},{"key":"S1073110526102903_r3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2104846"},{"key":"S1073110526102903_r34","unstructured":"34. Gingery, Derrick , \u201cCBER Director Marks\u2019 Intervention on Sarepta Gene Therapy Filing Decision Appears to Backfire,\u201d Pink Sheet Insights, April 15, 2023, https:\/\/insights.citeline.com\/PS148055\/CBER-Director-Marks-Intervention-On-Sarepta-Gene-Therapy-Filing-Decision-Appears-To-Backfire\/."},{"key":"S1073110526102903_r39","unstructured":"39. Rawson, \u201cUnger Unplugged.\u201d"},{"key":"S1073110526102903_r5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2110468"},{"key":"S1073110526102903_r42","unstructured":"42. Feuerstein, Adam and Mast, Jason , \u201cTracking the FDA Advisory Panel on Sarepta\u2019s Gene Therapy for Duchenne Muscular Dystrophy,\u201d STAT, May 12, 2023, https:\/\/www.statnews.com\/2023\/05\/12\/sarepta-gene-therapy-duchenne-muscular-dystrophy-fda-advisory-panel\/."},{"key":"S1073110526102903_r36","unstructured":"36. Karlin-Smith, Sarah , \u201cCaliff Sees Potential for New Emergency Use Authorities but Concerned About Industry Follow Through,\u201d Pink Sheet Insights, February 20, 2023, https:\/\/insights.citeline.com\/PS147747\/Califf-Sees-Potential-For-New-Emergency-Use-Authorities-But-Concerned-About-Industry-Follow-Through\/."},{"key":"S1073110526102903_r20","unstructured":"20. Karlin-Smith, Sarah , \u201cFDA\u2019s Pazdur: Accelerated Approval Is \u2018Under Attack,\u2019 Supporters Can\u2019t Afford to Remain Silent,\u201d Pink Sheet Insights, July 29, 2021, https:\/\/insights.citeline.com\/PS144719\/FDAs-Pazdur-Accelerated-Approval-Is-Under-Attack-Supporters-Cant-Afford-To-Remain-Silent\/."},{"key":"S1073110526102903_r62","unstructured":"62. The Editorial Board, \u201cDr. Makary and Mr. Hyde at the FDA,\u201d Opinion, Wall Street Journal, April 14, 2026, https:\/\/www.wsj.com\/opinion\/replimune-melanoma-rp1-fda-vinay-prasad-marty-makary-a45fa5bf; The Editorial Board, \u201cAnother Marty Makary Mistake.\u201d; The Editorial Board, \u201cWho\u2019s in Charge at the FDA?,\u201d Opinion, Wall Street Journal, February 24, 2026, https:\/\/www.wsj.com\/opinion\/vinay-prasad-fda-drug-approvals-disc-medicine-regenxbio-marty-makary-8488f514; 3 Tristan Manalac, \u201cMakary Defends Replimune Melanoma Rejection Again as FDA Tensions Build,\u201d BioSpace, May 6, 2026, https:\/\/www.biospace.com\/fda\/makary-defends-replimune-melanoma-rejection-again-as-fda-tensions-build."},{"key":"S1073110526102903_r38","unstructured":"38. Rawson, Kate , \u201cUnger Unplugged: FDA Needs Accelerated Approval to \u2018Take More Chances\u2019 \u2013 But Also a Clear Path to Withdrawal,\u201d Pink Sheet Insights, February 24, 2022, https:\/\/insights.citeline.com\/PS145755\/Unger-Unplugged-FDA-Needs-Accelerated-Approval-To-Take-More-Chances--But-Also-A-Clear-Path-To-Withdrawal\/."},{"key":"S1073110526102903_r54","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.10116"},{"key":"S1073110526102903_r59","unstructured":"59. Prasad and Makary, \u201cFDA\u2019s New Plausible Mechanism Pathway\u201d; \u201cConsiderations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies That Target Specific Genetic Conditions with Known Biological Cause,\u201d Center for Biologics Evaluation and Research, FDA, February 25, 2026, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/considerations-use-plausible-mechanism-framework-develop-individualized-therapies-target-specific; Lawrence, \u201cFDA to Lower Number of Trials.\u201d"},{"key":"S1073110526102903_r35","unstructured":"35. Lynch et al., \u201cExtending the US Food and Drug Administration\u2019s Postmarket Authorities.\u201d"},{"key":"S1073110526102903_r1","unstructured":"1. \u201cAccelerated Approval Program,\u201d Center for Drug Evaluation and Research, FDA, December 24, 2024, https:\/\/www.fda.gov\/drugs\/nda-and-bla-approvals\/accelerated-approval-program."},{"key":"S1073110526102903_r65","unstructured":"65. \u201c President Donald, J. Trump to Sign Right to Try Legislation Fulfilling the Promise He Made to Expand Healthcare Options for Terminal Americans,\u201d National Archives, https:\/\/trumpwhitehouse.archives.gov\/briefings-statements\/president-donald-j-trump-sign-right-try-legislation-fulfilling-promise-made-expand-healthcare-options-terminal-americans\/, last visited May 13, 2026."},{"key":"S1073110526102903_r50","article-title":"Three F.D.A. Advisers Resign Over Agency\u2019s Approval of Alzheimer\u2019s Drug","author":"Belluck","journal-title":"New York Times"},{"key":"S1073110526102903_r25","unstructured":"25. Milligan, Emily and McCurdy, Katherine R. , \u201cAduhelm Backlash Threatens to Reverse Progress in FDA\u2019s Reviews of Rare and Ultra-Rare Disease Drugs,\u201d STAT, September 14, 2021, https:\/\/www.statnews.com\/2021\/09\/14\/aduhelm-backlash-may-imperil-fda-reviews-ultra-rare-disease-drugs\/."},{"key":"S1073110526102903_r48","unstructured":"48. Rawson, \u201cUnger Unplugged.\u201d"},{"key":"S1073110526102903_r47","unstructured":"47. Karlin-Smith, Sarah , \u201cFDA\u2019s Pazdur Blames Trial Design Errors for Some PD-1\/L1 Failures, Foreshadows Potential Agency Leniency,\u201d Pink Sheet Insights, June 30, 2021, https:\/\/insights.citeline.com\/PS144554\/FDAs-Pazdur-Blames-Trial-Design-Errors-For-Some-PD1L1-Failures-Foreshadows-Potential-Agency-Leniency\/."},{"key":"S1073110526102903_r51","article-title":"6 Ways the FDA\u2019s Approval of Aduhelm Does More Harm than Good","author":"Gandy","year":"2021","journal-title":"STAT"},{"key":"S1073110526102903_r61","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.21721"},{"key":"S1073110526102903_r52","unstructured":"52. \u201cAccelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway,\u201d Oncology Center of Excellence, FDA, January 6, 2025, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/accelerated-approval-and-considerations-determining-whether-confirmatory-trial-underway."},{"key":"S1073110526102903_r17","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.2040"},{"key":"S1073110526102903_r4","article-title":"Accelerated Removal: FDA Making Use of New Authority to Withdraw Ineffective Drugs More Quickly","author":"Gaffney","year":"2024","journal-title":"AgencyIQ by POLITICO"},{"key":"S1073110526102903_r2","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518770648"},{"key":"S1073110526102903_r32","unstructured":"32. Gingery, \u201cCaliff Says Accelerated Approval A \u2018Different Objective.\u2019\u201d"},{"key":"S1073110526102903_r66","doi-asserted-by":"crossref","first-page":"3244","DOI":"10.1038\/s41591-025-03948-5","article-title":"Diffusing Authority to Make Drug Approval Decisions at the US Food and Drug Administration","volume":"31","author":"Rhodes","year":"2025","journal-title":"Nature Medicine"},{"key":"S1073110526102903_r55","unstructured":"55. Lynch, Holly Fernandez and Ramachandran, Reshma , \u201cBy Loosening Standards, the FDA Isn\u2019t Doing Rare-Disease Patients Any Favors,\u201d Los Angeles Times, October 19, 2025, https:\/\/www.latimes.com\/opinion\/story\/2025-10-19\/fda-approval-rare-disease-drugs-treatments."},{"key":"S1073110526102903_r11","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.4175"},{"key":"S1073110526102903_r63","unstructured":"63. The Editorial Board, \u201cVinay Prasad Is Out at the FDA \u2014 Again,\u201d Opinion, Wall Street Journal, March 6, 2026, https:\/\/www.wsj.com\/opinion\/fda-marty-makary-vinay-prasad-uniqure-accelerated-approvals-ab0548ff."},{"key":"S1073110526102903_r18","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-med-051022-043645"},{"key":"S1073110526102903_r33","unstructured":"33. Sutter, \u201cGene Therapy.\u201d"},{"key":"S1073110526102903_r46","unstructured":"46. Sutter, Sue , \u201cAccelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules,\u201d Pink Sheet Insights, May 8, 2024, https:\/\/insights.citeline.com\/PS154672\/Accelerated-Approval-Withdrawing-Gene-Therapies-Could-Be-Easier-Than-Small-Molecules\/."},{"key":"S1073110526102903_r28","unstructured":"28. Sutter, Sue , \u201cGene Therapy: Years After Accelerated Approval, Will US FDA Still Be Asking \u2018Does It Work?,\u2019\u201d Insights, February 20, 2023, https:\/\/insights.citeline.com\/PS147744\/Gene-Therapy-Years-After-Accelerated-Approval-Will-US-FDA-Still-Be-Asking-Does-It-Work\/."},{"key":"S1073110526102903_r49","unstructured":"49. Karlin-Smith, Sarah , \u201cWoodcock: High Prices Create Problems for Entire Accelerated Approval Program,\u201d Pink Sheet Insights, January 4, 2022, https:\/\/web.insights.norstella-labs.com\/PS145401\/Woodcock-High-Prices-Create-Problems-For-Entire-Accelerated-Approval-Program\/."},{"key":"S1073110526102903_r44","unstructured":"44. Sutter, \u201cAccelerated Approval Withdrawals.\u201d"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110526102903","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:05:50Z","timestamp":1790917550000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110526102903\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,2]]},"references-count":67,"alternative-id":["S1073110526102903"],"URL":"https:\/\/doi.org\/10.1017\/jme.2026.10290","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,2]]}}}