While the Orphan Battles Wages, Jazz Takes a Loss
FDA Law
NOVEMBER 6, 2024
As the Court explains, an orphan drug may not be the “same drug” as the same active moiety under the Orphan Drug Act and FDA’s longstanding implementing regulations if one is “clinically superior” than the other by way of greater efficacy, greater safety, or major contribution to patient care (“MC-to-PC”). Black Ball Freight Serv. ,
Let's personalize your content