title: Perspective: communications with the Food and Drug Administration on the development pathway for a cell-based therapy: why, what, when, and how?
abstract: Effective interaction between key stakeholders and the U.S. Food and Drug Administration (FDA) is central to successfully navigating the regulatory process and advancing new therapies into clinical trials. This is especially true when developing cell-based therapies, which pose unique challenges to demonstrating safety and effectiveness. There are numerous opportunities for developers of a new cell therapy to interact with the regulatory agency, through both formal and informal processes. It is important to understand how to maximize the productivity of dialogue with the FDA and develop an effective regulatory strategy. This article provides an overview of the types of interactions with the FDA that are available throughout the regulatory process. This article also notes some common pitfalls to avoid and directs readers to additional references and resources to help inform cell therapy researchers and product developers and enable successful regulatory interactions.
authors.affiliation: California Institute for Regenerative Medicine, San Francisco, CA, USA. efeigal@cirm.ca.gov
authors.forename: Ellen G
authors.initials: EG
authors.lastname: Feigal
authors.forename: Katherine
authors.initials: K
authors.lastname: Tsokas
authors.forename: Jiwen
authors.initials: J
authors.lastname: Zhang
authors.forename: Marc V
authors.initials: MV
authors.lastname: Cromer
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Whittlesey
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Werner
mesh_terms: D017690:Cell Transplantation; D003142:Communication; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration