FDA Withdraws Proposed Rule for Drug Labels

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The following was provided by Pharmacy Times:

FDA officials said in December 2018 that they will withdraw a 2013 proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, that would have made the same procedure for updating labels that applies to brand name drugs apply to generics.1 If the rule had been carried out, generic drug manufacturers would have had to update safety information on their drug labels as health risks were discovered, as is the case for brand name drugs. Currently, generic drug makers do not update their labels unless ordered to do so by the FDA. CLICK HERE to read more.

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