In Reply Dr Tanimoto and colleagues suggest that 3 additional characteristics of novel therapeutics or features of their regulatory approval should be considered when examining potential predictors of postmarket safety events after approval by the FDA: expected length of treatment, first approval by a peer regulator, such as the EMA, and total number of patients participating in the manufacturer’s pivotal trial program. We appreciate these suggestions and in response have examined whether postmarket safety event risk was associated with either expected length of treatment or relative number of patients participating in premarket clinical studies. However, we did not examine first approval by a peer regulator because new drug application submission occurs more or less simultaneously to the FDA and EMA, with approval within a few months.¹

回复Tanimoto博士及其同事建议，在审查FDA批准后的上市后安全事件的潜在预测因素时，应考虑3种新疗法的新特征或获得监管部门批准的特征：预期的治疗时间，同行监管机构的首次批准，例如EMA，以及参与制造商关键试验计划的患者总数。我们赞赏这些建议，并在回应中检查了上市后安全事件的风险是否与预期的治疗时长或参与上市前临床研究的患者相对人数有关。但是，我们没有审查同行监管机构的首次批准，因为新药申请的提交或多或少同时发生在FDA和EMA的批准中，并在几个月内获得批准。^1个