We acknowledge Janssen's reply to concerns raised about the regulatory process that brought esketamine for treatment-resistant depression to the market. We regret the lack of response from the US Food and Drug Administration. We forwarded our concerns to the Committee for Medicinal Products for Human Use of the European Medicines Agency, whose written response elaborated on the same main arguments as Janssen's reply (Committee for Medicinal Products for Human Use, European Medicines Agency, personal communication).

中文翻译：

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批准艾司他明治疗难治性抑郁症-作者的回复。

我们感谢扬森（Janssen）对监管程序的担忧，该监管程序将艾司他明用于治疗难治性抑郁症推向市场。我们感到遗憾的是，美国食品药品监督管理局没有做出回应。我们将关注的问题转发给了欧洲药品管理局用于人类使用的药用产品委员会，该委员会在书面答复中阐述了与詹森的答复相同的主要论点（欧洲药品管理局用于人类使用的药用产品委员会，个人来文）。