FDA Pharmaceutical Quality Documents·· 2021-04-08AI 评分55
FDA MAPP 5310.3 Rev. 2：新药申请与生物制品许可申请中CMC变更预先批准补充申请的加速审评请求
MAPP 5310.3 Rev. 2 Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes
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FDA 药品质量文件页面列出 MAPP 5310.3 Rev. 2，主题为新药申请和生物制品许可申请中 CMC 变更预先批准补充申请的加速审评请求。该文件版本为 Rev. 2，本次材料未提供正文内容。
来源：FDA Pharmaceutical Quality Documents · fda.gov