Testing of Adenoviral Vector Gene Transfer Products: FDA Expectations

This chapter describes the agency requirements and guidelines for drug development of adenoviral-containing products. The Food and Drug Administration (FDA) assessment of safety and ultimately effectiveness of adenovirus containing products involves thorough evaluation of the information contained in the Investigational New Drug Application (IND), and any supporting information cross-referenced to another IND or drug master file. Many factors contribute to development of FDA recommendations and requirements for characterization of adenovirus vectors. The FDA receives input and feedback from a variety of sources in formulating recommendations regarding adenovirus manufacturing and characterization. The recommendations may change with advances in technology and through accumulating experience. FDA considers the potential risks and benefits of each vector product and each proposed clinical trial when making its recommendations. The FDA is cognizant of the need for flexibility in its recommendations and will consider many factors, including the intended target population, the seriousness of the disease under study, the potential benefits and risks from the investigational product, when advising sponsors about their adenovirus development program.