title: Progressive approval: a proposal for a new regulatory pathway for regenerative medicine.
abstract: To stimulate a broad discussion between academics, practicing physicians, corporate managers, and members of the regulatory community, we describe a proposal for a new regulatory pathway for human cell- and tissue-based products. The new components of the pathway are intended to accelerate patient access to a wide array of novel therapeutics, strengthen R&D infrastructure, and expand patient numbers and time lines for efficacy testing through a transparent and publicly accessible website for real-time reporting of outcome data and 5- to 10-year, long-term follow-up.
authors.affiliation: Skeletal Research Center, Biology Department, Case Western Reserve University, Cleveland, Ohio, USA.
authors.forename: Arnold I
authors.initials: AI
authors.lastname: Caplan
authors.forename: Michael D
authors.initials: MD
authors.lastname: West
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards* / Q000639:trends*; D006801:Humans; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence* / Q000592:standards* / Q000639:trends*