FDA Generic Final Rule Requires Polymorph Test Data For Patent Listing
This article was originally published in The Tan Sheet
Executive Summary
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
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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
FDA Questions First-To-File Exclusivity As Generic Reforms Pass Senate
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