FDA Updates to Forms 356h and 1571

FDA has recently revised Form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and Form 1571: Investigational New Drug Application (IND) to align with FDA User Fee requirements as well as make other improvements to data quality and ease of use.

These forms are required to be submitted with NDAs, ANDAs, BLAs and INDs. FDA uses this information in the review process and companies should be aware of these updates and are required to use the most current version of these forms.

Companies need to use the most recent update to Forms 356h and 1571 in their submissions.

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