Role of the FDA in Guiding Drug Development

Publisher Summary This chapter discusses the role of the Food and Drug Administration (FDA) in guiding drug development. The FDA guides drug development in many different ways such as (1) by interpreting laws, rules, and regulations; (2) by disseminating policy statements that may otherwise be vague or unclear; (3) by providing advice and sharing experiences and expertise in face-to-face meetings and through written agreements and letters; (4) by domestic and international guidances; (5) by planned telephone conferences and/or scheduled videoconferences; and (6) by the FDA web site. The FDA also guides drug development by holding closed or open advisory committee meetings. These meetings facilitate the regulatory review and FDA approval process by bringing together external experts to assess data, recommend need for new studies, and address specific questions formulated by the FDA to help resolve scientific or clinical problems related to the drug development process or a specific product approval. The most widespread, effective, and important way that the FDA communicates with sponsors and guides drug development is through guidances issued either by the FDA or by the International Conference on Harmonization (ICH). The FDA should take the lead in developing a national Critical Path Opportunities List to bring concrete focus to these tasks and prepare for the challenges in drug development in the future.