Generic Exclusivity Usefulness Needs Review, FDA's Dickinson Says
This article was originally published in The Tan Sheet
The necessity of 180-day generic exclusivity should be reviewed, FDA Associate Counsel for Drugs Elizabeth Dickinson said at the Food & Drug Law Institute's Hatch/Waxman conference in Washington, D.C. Dec. 11.
You may also be interested in...
Sens. John McCain (R-Ariz.) and Charles Schumer (D-N.Y.) intend to rally support in the next session of Congress for legislation introduced Sept. 14 that would ease the FDA approval process for generic drugs.
Generic drug firms eligible for 180 days of marketing exclusivity would lose their eligibility if the exclusivity period were not triggered within 180 days of tentative approval of another ANDA referencing the same listed drug. FDA spells out this condition in an Aug. 6 proposed rule.
Perrigo promotes in pricing, planning