Guidance for regulated biotech trials in the U.S.

Abstract

<p>This creative component provides an overview of what must be done to comply with U.S. regulations for conducting regulated biotech trials in a field setting which are different than the requirements for contained facility studies (lab or greenhouse). Many risks must be assessed and addressed by an organization wishing to conduct the regulated biotech trials, and the USDA must approve of these methods to address risk.</p> <p>The audience for this creative component is those with a background in agriculture and knowledge of biotech materials. The information addresses how to manage regulated biotech trials per USDA requirements in the United States but will not provide a background on the creation of biotech materials or how products are deregulated or approved for commercial sale. This creative component will be helpful for anyone considering a role in compliance. It is important to keep in mind this creative component outlines what to do but not how to do it. The compliance processes are up to each organization to address. This paper represents a snapshot in time as regulations continue to change.</p>