21 Page Response Again Confirms FDA’s Previous Position on ODE and H-W Exclusivity Carve-outs
Without going into a lot of detail, suffice it to say that the FDA has again rebuffed attempts to delay a 505(j) or 505(b)(2) version of a drug product protected by various periods of Orphan Drug Exclusivity (ODE) and/or Hatch-Waxman (H-W) exclusivity, in a November 6, 2017 denial of a Citizen Petition from the innovator […]