Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

Roberts SA; Allen JD; Sigal EV

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Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

机译：尽管对FDA审查程序提出了批评，但新的癌症药物在美国比在欧洲更快地送达患者。

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The US Food and Drug Administration is often criticized as inefficient compared to its European counterpart, the European Medicines Agency. This criticism is especially common in the field of oncology, where severely ill patients have few therapeutic options. We conducted a direct drug-to-drug comparison of the two regulatory agencies' approvals of new oncology drugs. We found that contrary to public assertions, the median time for approval for new cancer medicines in the United States was just six months--and that these new anticancer medicines are typically available in the United States before they are in Europe. Our findings reinforce the need for strong financial and public support of the Food and Drug Administration, so that such medicines can continue to be made available speedily to patients in need.

机译：与美国的欧洲药品管理局相比，美国食品药品监督管理局经常被批评效率低下。这种批评在肿瘤学领域尤其普遍，在肿瘤学领域，重病患者几乎没有治疗选择。我们对两家监管机构对新肿瘤药物的批准进行了直接的药物比对。我们发现，与公开声明相反，在美国批准新的癌症药物的中位时间仅为六个月，而且这些新的抗癌药物通常在美国上市之后才在欧洲上市。我们的发现加强了对美国食品药品管理局的财政和公共支持的需求，以便可以继续将此类药物迅速提供给有需要的患者。

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《Health affairs》 |2011年第7期|共7页
作者
Roberts SA; Allen JD; Sigal EV;
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中图分类预防医学、卫生学;
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1. Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe. [J] . Roberts SA, Allen JD, Sigal EV Health affairs . 2011,第7期

机译：尽管对FDA审查程序提出了批评，但新的癌症药物在美国比在欧洲更快地送达患者。
2. FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials [J] . Laboratory industry report . 2019,第11期

机译：FDA手表：同时审查癌症药物试验中使用的IVD测试的新方法
3. Patient-reported outcomes in breast cancer FDA drug labels and review documents [J] . Hong Kyungwan, Majercak Kayleigh R., Villalonga-Olives Ester, Journal of Patient-Reported Outcomes . 2021,第1期

机译：患者报告的乳腺癌FDA药物标签和审查文件的结果
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. Role of Patient Advocacy Stakeholders in Science-Based Regulatory Policy at the U.S. Food and Drug Administration (FDA) [D] . Kuehn, Carrie Melissa. 2017

机译：患者倡导利益相关者在美国食品和药物管理局（FDA）的科学研究政策中的作用
6. Patient-reported outcomes in breast cancer FDA drug labels and review documents [O] . Kyungwan Hong, Kayleigh R. Majercak, Ester Villalonga-Olives, 2021

机译：患者报告的乳腺癌FDA药物标签和审查文件的结果
7. PHP22 Evaluating Criticism Of The Fda Accelerated Approval Pathway - Ema Evaluation Of Drugs That Have Been Withdrawn Following Accelerated Approval By The Fda [O] . Macaulay R. 2014

机译：PHP22评估对Fda加速批准途径的批评-Ema评估Fda加速批准后撤回的药物
8. FDA's (Federal Drug Administration) Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies [R] . Pennington, J. C. 1988

机译：FDa（联邦药物管理局）对新药的评论：审查和报告临床研究过程中所需的变化

Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

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