FDA Week - 09/20/2019

FDA Will Reject Sham Citizen Petitions; Refer Cases To FTC

By Rachel Cohrs / September 19, 2019 at 2:24 PM
FDA plans to reject citizen petitions submitted primarily to delay generic and biosimilar competition, and the agency will refer offenders to the Federal Trade Commission, according to final guidance released Wednesday (Sept. 18). The final guidance is similar to draft guidance released in October 2018 . FDA also will report to Congress annually on citizen petitions aimed at delaying competition. FDA emphasized that it will only allow citizen petitions to delay approval of generics or biosimilars when necessary to protect...


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