Are certain kinds of rDNA constructs considered “safe”?
All constructs and the resulting GE animals will be considered on a case-by-case basis. At this time, we do not believe that certain constructs will be predetermined to be “safe” or “not safe”. Q: What happens during the research phase of developing a GE animal? A: The agency refers to the “research phase” as the “investigational phase” of the development of GE animals containing rDNA constructs. During this phase, developers (referred to as sponsors), in general, can use various rDNA constructs and intermediates to arrive at a construct in an animal that they believe will serve as the progenitor of the line of GE animals that they wish to develop. We will work with sponsors to ensure that records are kept appropriately, that investigational animals are disposed of in a safe manner that potential environmental risks are assessed, and that data and information suitable to a New Animal Drug Application (NADA) are being developed. Q: What kinds of information are required for an NADA subm
