The FDA's Rejection of Citizen Petitions

The FDA's regulations require a potential liticant to go to it. It's called exhausting your administrative remedies. In 2002, some of the plaintiffs in this very case filed a citizen position petition with the FDA challenging its initial approval of the drug. And then they did so again after the 2016 changes were made. They're often filed by persons who have a special expertise or something that they want the agency to consider.

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