Points to Consider in the Manufacture and Testing of Therpeutic Products for Human Use Derived from Transgenic Animals

Regulatory Resource: Points to Consider in the Manufacture and Testing of Therpeutic Products for Human Use Derived from Transgenic Animals

Description:

This document presents considerations of the Food and Drug Administration (FDA) with regard to the use of transgenic animals to produce FDA-regulated drugs and biological products intended for human use. These considerations include important scientific questions that should be addressed by sponsors during the preparation of IND, PLA, ELA or NDA submissions. This guidance is expected to assist sponsors in determining what scientific data should be submitted in support of applications for new therapeutic products generated in transgenic animals.

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