Generic Exclusivity Forfeiture Provisions Put FDA In “Hot Seat”
Executive Summary
FDA is grappling with how to define triggers for forfeiture of generic exclusivity as it develops regulations to implement changes in Hatch/Waxman created by the Medicare Modernization Act of 2003
You may also be interested in...
Generic Exclusivity Forfeiture Provision Hits Snag In Courts; FTC Wants Fix
A key provision of the Medicare Modernization Act's forfeiture provision for ANDA filers' 180-day exclusivity could be moot if courts continue to refuse to hear petitions by generic companies for declaratory judgments
Generic Exclusivity Forfeiture Provision Hits Snag In Courts; FTC Wants Fix
A key provision of the Medicare Modernization Act's forfeiture provision for ANDA filers' 180-day exclusivity could be moot if courts continue to refuse to hear petitions by generic companies for declaratory judgments
Failure To Launch: Pravachol, Zocor And The Future Of 180-Day Exclusivity
Some of the most anticipated generic launches in recent years will be more limited than originally projected following court decisions creating 180-day exclusivity periods for generics of Bristol-Myers Squibb's Pravachol and Merck's Zocor