This document provides guidance to industry on good risk assessment practices during the development of prescription drug products, including biological drug products. This is one of three guidances that were developed to address risk management activities. Specifically, this document discusses the generation, acquisition, analysis, and presentation of premarketing safety data. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This document is displayed here for educational reference purposes only.
The document can be found on the FDA website at the following downloads site address link, click here.