title: Regulatory challenges, reimbursement, and risk-benefit assessment.
authors.forename: A
authors.initials: A
authors.lastname: Breckenridge
mesh_terms: D003625:Data Collection; D055808:Drug Discovery; D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D018570:Risk Assessment / Q000191:economics* / Q000331:legislation & jurisprudence*; D013673:Technology Assessment, Biomedical; D016896:Treatment Outcome; D014481:United States