Citizen Petition Reform Proposals Include User Fees, Payments For Lost Profits
Executive Summary
User fees for citizen petitions may discourage abuse of the process, Sandoz VP-Intellectual Property & Regulatory Shashank Upadhye said Sept. 30 at the Institute for International Research's Annual Generic Drugs Summit in Washington, D.C
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Citizen Petitions: FDA Will Speed Reviews Via Centralization, Not Decoupling
FDA is taking several administrative steps toward streamlining its review of citizen petitions, including designating staff to concentrate on the submissions
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