title: Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States.
abstract: Tissue-engineered and regenerative medicine products are promising innovative therapies that can address unmet clinical needs. These products are often combinations of cells, scaffolds, and other factors and are complex in both structure and function. Their complexity introduces challenges for product developers to establish novel manufacturing and characterization techniques to ensure that these products are safe and effective prior to clinical trials in humans. Although there are only a few commercial products that are currently in the market, many more tissue-engineered and regenerative medicine products are under development. Therefore, it is the purpose of this article to help product developers in the early stages of product development by providing insight into the Food and Drug Administration (FDA) process and by highlighting some of the key scientific considerations that may be applicable to their products. We provide resources that are publically available from the FDA and others that are of potential interest. As the provided information is general in content, product developers should contact the FDA for feedback regarding their specific products. Also described are ways through which product developers can informally and formally interact with the FDA early in the development process to help in the efficient progression of products toward clinical trials.
authors.affiliation: Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA. mark.lee@fda.hhs.gov
authors.forename: Mark H
authors.initials: MH
authors.lastname: Lee
authors.forename: Judith A
authors.initials: JA
authors.lastname: Arcidiacono
authors.forename: Anastacia M
authors.initials: AM
authors.lastname: Bilek
authors.forename: Jeremiah J
authors.initials: JJ
authors.lastname: Wille
authors.forename: Caitilin A
authors.initials: CA
authors.lastname: Hamill
authors.forename: Keith M
authors.initials: KM
authors.lastname: Wonnacott
authors.forename: Martha A
authors.initials: MA
authors.lastname: Wells
authors.forename: Steven S
authors.initials: SS
authors.lastname: Oh
mesh_terms: D002986:Clinical Trials as Topic; D004335:Drug and Narcotic Control; D006801:Humans; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence*; D023822:Tissue Engineering / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration