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United States Moves Publication Date of the Final Rule for Labeling of Generic Drugs

June 17, 2016

The U.S. Food and Drug Administration (FDA) has moved the publication date of the Final Rule intended for the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.

The final rule would allow generic drug makers to independently update safety warnings, which only brand-name drug makers can currently do before receiving FDA permission.

The new publication of the final rule will be April 2017. The original date was spring of 2016.