FDA Questions First-To-File Exclusivity As Generic Reforms Pass Senate
This article was originally published in The Tan Sheet
FDA has reservations about the current first-to-file basis for 180-day exclusivity, FDA Chief Counsel Daniel Troy acknowledged at a June 17 Senate Judiciary Committee hearing on generic drug reforms
You may also be interested in...
FDA's final rule to reform Hatch/Waxman requires an innovator company to test data to establish that a polymorph claimed in a patent is the same as the active ingredient in the NDA
A bill to require reporting of brand/generic patent settlements to the Federal Trade Commission appears ready to move early in the 108th Congress
The Federal Trade Commission supports a limit of one 30-month stay of approval on generic drugs in patent litigation