Waxman’s Generic Reform: No 30-Month Stay, Early Declaratory Judgements
This article was originally published in The Tan Sheet
Executive Summary
Rep. Henry Waxman (D-Calif.) is developing generic drug reform legislation that would eliminate the 30-month stay of approvals on ANDAs subject to patent litigation
You may also be interested in...
FDA’s Generic Priorities: McClellan Lays Out Ambitious Agenda At GPhA
FDA is developing a process to flag NDAs that may pose difficulties for future generic development, Commissioner Mark McClellan, MD/PhD, said at the Generic Pharmaceutical Association annual meeting in Rio Grande, Puerto Rico Jan. 29
Generic Drug Reforms: FTC Notification Bill Appears Ready To Move In 2003
A bill to require reporting of brand/generic patent settlements to the Federal Trade Commission appears ready to move early in the 108th Congress
Hatch/Waxman Reform Should Await Pending Supreme Court Decision – Hatch
Congress should wait for an upcoming Supreme Court ruling on the Doctrine of Equivalents before beginning serious work on re-drafting the Hatch/Waxman Act, Sen. Orrin Hatch (R-Utah) said