Drug approval: clinical evidence often inadequate

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Drug approval: clinical evidence often inadequate

机译：药物批准：临床证据往往不足

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In the United States, as in Europe, drugs are approved on the basis of very limited clinical evidence, putting patient safety at risk. Every month, Prescrire's New Products section shows that drugs are approved in the European Union on the basis of clinical evidence that is often insufficient. Is the situation better in the United States?

机译：在美国，如在欧洲，毒品在非常有限的临床证据的基础上获得批准，使患者安全面临风险。每个月，预定产品的新产品部分表明，药物在欧洲联盟批准，临床证据通常不足。在美国的情况是更好的吗？

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《Prescrire international》 |2016年第169期|共1页
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正文语种 eng
中图分类药学;
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专利

1. Drug approval: clinical evidence often inadequate [J] . Prescrire international . 2016,第169期

机译：药物批准：临床证据往往不足
2. Food and Drug Administration vs vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval [J] . Joppi Roberta, Bertele Vittorio, Vannini Tommaso, British Journal of Clinical Pharmacology . 2020,第1期

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3. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014 [J] . Rathi Vinay K., Wang Bo, Ross Joseph S., Otolaryngology--head and neck surgery: official journal of American Academy of Otolaryngology-Head and Neck Surgery . 2017,第4期

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4. Formalizing Evidence Type Definitions for Drug-Drug Interaction Studies to Improve Evidence Base Curation [C] . Joseph Utechr, Mathias Brochhausen, John Judkins, MEDINFO . 2017

机译：用于药物互动研究的正式证据类型定义，以改善证据基础策策
5. Meta-Analysis to Identify and Evaluate Factors Associated with Regulatory Approval of Orphan Drugs (OD) to Develop an Algorithm for Predicting Regulatory Approval (Success) and to Develop a Standardized Tool to Improve Orphan Drug Portfolio Decision-Making [D] . Florent, Milky C. 2019

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6. Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval [O] . Roberta Joppi, Vittorio Bertele, Tommaso Vannini, 2020

机译：食品和药物管理局与欧洲药物局：在批准时审查时间和新药的临床证据
7. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 [O] . Aviv Ladanie, Andreas M. Schmitt, Benjamin Speich, 2020

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8. New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials [R] . 2010

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Drug approval: clinical evidence often inadequate

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