FDA's expectations on transgenic products

WASHINGTON - The FDA Center for Biologics Evaluation and Research (CBER) issued a "Points to Consider" memo that represents its latest thoughts about regulating the manufacture and testing of therapeutic products for human use derived from transgenic animals.

Specifically, the document outlines data the agency expects to be submitted in support of applications for drugs, biological products and devices, including tissues or cell preparations, derived or harvested from transgenic animals...