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US FDA aims to ensure citizen petitions do not improperly delay generics

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has proposed amending its regulations to ensure that citizen petitions are not used as a tool by brand name drug companies and others to improperly delay the approval of generics and certain new drug applications submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act1.

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