1.0Registrarhttps://legacy.registrarcorp.com/zh/Mason Granduskyhttps://legacy.registrarcorp.com/zh/author/mgrandusky/Adverse Event Contact for OTC Drugsrich600338<blockquote class="wp-embedded-content" data-secret="6v8fx7A7jg"><a href="https://legacy.registrarcorp.com/zh/fda-drugs/adverse-event/">Adverse Event Contact for OTC Drugs</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://legacy.registrarcorp.com/zh/fda-drugs/adverse-event/embed/#?secret=6v8fx7A7jg" width="600" height="338" title="“Adverse Event Contact for OTC Drugs” — Registrar" data-secret="6v8fx7A7jg" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script>
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https://legacy.registrarcorp.com/wp-content/uploads/2019/08/press_release.jpg1650500[vc_row][vc_column width=”1/2″][vc_column_text] 非处方药不良事件联系人 [/vc_column_text][vc_column_text]美国 FDA 要求大多数非处方药 (OTC) 的标签上包含能够接收和记录消费者严重不良事件报告的美国实体的联系信息。不符合此要求的产品将被 FDA 视为“贴错标签”，并会被扣留和拒绝入境。 作为贵司的美国联系人，Registrar Corp 会迅速将消费者报告的严重不良事件转发给贵司。如需更多信息，只需填写下表。[/vc_column_text][vc_column_text css=”.vc_custom_1682960096970{padding-top: 25px !important;}”] 非处方药的严重不良事件报告要求 膳食补充剂和非处方药消费者保护法包括以下针对大多数非处方药产品严重不良事件报告的要求： • 报告必须包含零售包装上或零售包装内的标签副本 • 责任人必须在收到初始报告后的 15 个工作日内提交报告 • 严重不良事件报告必须通过 MedWatch 表格提交。报告可以纸质或电子方式提交（分别为 FDA 3500A 表格或 FDA 安全报告门户）[/vc_column_text][/vc_column][vc_column width=”1/2″][vc_column_text][/vc_column_text][/vc_column][/vc_row]