1.0Registrarhttps://legacy.registrarcorp.com/zh/Mason Granduskyhttps://legacy.registrarcorp.com/zh/author/mgrandusky/FDA对于药物配制外包企业的法规要求rich600338<blockquote class="wp-embedded-content" data-secret="OdoAqopdCX"><a href="https://legacy.registrarcorp.com/zh/fda-drugs/outsourcing/">FDA对于药物配制外包企业的法规要求</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://legacy.registrarcorp.com/zh/fda-drugs/outsourcing/embed/#?secret=OdoAqopdCX" width="600" height="338" title="“FDA对于药物配制外包企业的法规要求” — Registrar" data-secret="OdoAqopdCX" 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][vc_row_inner][vc_column_inner][vc_column_text] FDA对于药物配制外包企业的法规要求 在FDA注册为外包型企业的药物配制企业可能可以免于遵守FDA的某些法规要求，包括：（i）免于递交新药申请（NDA）与简略新药申请（ANDA）；（ii）只要符合了《食品、药品及化妆品法案》第503B章节的某些特定要求就可以免于在药品的标签上添加使用说明。 Registrar Corp可以为外包型企业担任其在FDA的注册代表。 若您想指定Registrar Corp作为贵司的注册代表，您需要要完成如下步骤：[/vc_column_text][vc_column_text][/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]