180-Day Exclusivity Must Begin Within 180-Day "Triggering Period" - FDA
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
Supplements Derived From Elk, Deer Exposed To CWD Due For Rulemaking
FDA will issue a proposed rule prohibiting use of dietary supplements and cosmetics derived from animals exposed to chronic wasting disease on a date "to be determined," according to the agency's "unified agenda" published in the May 14 Federal Register.
Supplements Derived From Elk, Deer Exposed To CWD Due For Rulemaking
FDA will issue a proposed rule prohibiting use of dietary supplements and cosmetics derived from animals exposed to chronic wasting disease on a date "to be determined," according to the agency's "unified agenda" published in the May 14 Federal Register.
Supplements Derived From Elk, Deer Exposed To CWD Due For Rulemaking
FDA will issue a proposed rule prohibiting use of dietary supplements and cosmetics derived from animals exposed to chronic wasting disease on a date "to be determined," according to the agency's "unified agenda" published in the May 14 Federal Register.