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FDA Proposal To Allow Generic Drug Label Updates

The U.S. Food and Drug Administration (FDA) just issued a proposed rule to allow generic drug makers to update labels should they receive information on potential safety issues associated with their drugs.
Today, only brand name drug makers are permitted to make such label changes. The proposed rule, if approved, will also enable litigation to proceed against generic drug manufacturers, noted The New York Times.
The Supreme Court has ruled that, under state law, the makers of generic drugs may not be sued for adverse reactions allegedly associated with their products, finding that companies that produce branded drugs are liable for any inadequacies on their drugs warning labels.

By |2018-09-03T07:32:03+00:00July 25th, 2018|General|0 Comments

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