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CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

 

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CRITical Thinking Blog

Federal Judge Rules in FDA's Favor in Dispute Over Pediatric Exclusivity: A Win for the Agency, Patients, and Clinical Evidence

February 21, 2018
By Jeanie Kim, Amy Kapczynski, Joseph S. Ross

On February 17, 2018, a federal judge in the D.C. District Court affirmed the U.S. Food and Drug Administration's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster drug cinacalcet (Sensipar).

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