Legislation Requiring Greater Disclosure by Pharmaceutical Brands
Monday, December 21, 2020 Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if enacted, will require brand pharmaceutical companies to submit more information about their innovator products. Potential Changes to Orange Book Listing Requirements for Non-Biologics Drugs As part of its current obligations, an innovator produc...
Orange Book Listing Requirements Napproved Drug Products Therapeutic Equivalence Evaluations Hatch Waxman Act Orange Book Transparency Act Orange Book Act
Source: natlawreview.com