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FDA again delays generic labeling rule
Modern Healthcare

For the third time, the FDA has delayed a rule requiring generic-drug companies to update product labels if they receive new safety information.

To the dismay of patient advocates and the pleasure of generic-drug makers, the agency is now projecting the final rule won’t be published until April 2017. The draft regulations were issued in 2013, and the final rule was widely expected to arrive this spring.

The regulations were crafted in the wake of the Supreme Court’s 2011 decision in Pliva v. Mensing. The court ruled that generic-drug companies cannot be held liable for failing to warn patients about the risks of their products because the companies had no control over what the warning labels said.