FDA takes action to speed safety information updates on generic drugs

22 November 2013

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labelling.
Under current law, generic and brand drug manufacturers are required to promptly review safety information about their drugs and comply with the FDA’s reporting and recordkeeping requirements. When new information becomes available that causes the product labelling to be inaccurate, all drug manufacturers must take steps to update the labelling (FDA News Release, 8 November 2013).
Click here for the full FDA News Release.
Click here for the proposed rule.

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