Pediatric Exclusivity: Court Backs US On When Studies 'Fairly Respond' To Requests
Executive Summary
However, FDA must explain why denial of Sensipar's pediatric exclusivity was consistent with exclusivity award for J&J's Ortho Tri-Cyclen, US judge says. In swipe at plaintiff Amgen, court says pediatric study reports themselves guide exclusivity determinations, not the amount of effort a sponsor puts into those studies.
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What Will FDA Do If Supreme Court Curtails Chevron Deference?
Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.
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