title: The safe harbor provision of the Hatch-Waxman Act: present scope, new possibilities, and international considerations.
authors.affiliation: Pennie & Edmonds, L.L.P., New York, NY, USA
authors.forename: Brian D
authors.initials: BD
authors.lastname: Coggio
authors.forename: F Dominic
authors.initials: FD
authors.lastname: Cerrito
mesh_terms: D002170:Canada; D017277:Drug Approval; D005060:Europe; D005544:Forecasting; D006801:Humans; D007391:International Cooperation; D007564:Japan; D007880:Legislation, Drug / Q000639:trends; D011786:Quality Control; D013810:Therapeutic Equivalency; D014481:United States