title: New horizons in pharmaceutical regulation.
abstract: A life cycle approach to pharmaceutical regulation, in which the benefit-risk balance of new drugs continues to be robustly assessed following market approval, is emerging in both the United States and Europe.
authors: Medicines and Healthcare products Regulatory Agency, London                 SW1W 9SZ, UK.
authors: Alasdair
authors: A
authors: Breckenridge
authors: Michelle
authors: M
authors: Mello
authors: Bruce M
authors: BM
authors: Psaty
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D004364:Pharmaceutical Preparations; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations