title: The new FDA combination products programme.
abstract: The United States (US) Food and Drug Administration (FDA) has established a Combination Products Programme and developed a new internal procedure to increase its effectiveness in regulating products consisting of combinations of drugs, devices and biological products. This article provides a brief overview of the FDA regulation of combination products and discusses the new Programme.
authors.affiliation: Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, 1-00153 Rome, Italy. donawa@srd.it
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D001688:Biological Products / Q000592:standards; D003254:Consumer Advocacy / Q000331:legislation & jurisprudence; D003657:Decision Making; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration
chemical_list: D001688:Biological Products