Authorizing manufacturers of generic drugs to update safety labels independently, without waiting for Food and Drug Administration (FDA) approval or for the brand name equivalent to change its label, is a sensible rule proposed by the FDA and will give both patients and doctors more timely warnings of emerging risks and allow patients to hold generic drug companies liable in court, said Sarah Rooney, Director of Regulatory Affairs for the American Association for Justice, in a recent New York Times editorial. The opinion piece was prompted by strong opposition to the plan by generic drug makers who fear lawsuits from ... Read More
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