Product Development Under FDAs Animal Rule: Understanding FDAs Expectations and Potential Implications for Traditional Development Programs

This article reviews how different products met the requirements for licensure under the Animal Rule, based on information publicly available on FDA’s website. The primary aim of this manuscript is to offer an understanding of FDA’s interpretation of relevant regulations and guidances in the context of this licensure pathway. Some of the methods used for Animal Rule approvals may also have potential application in more traditional development programs. Thus, this article may also offer insight into methods for accelerating product development in general.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Regulatory Science Source Type: research