FDA Calls For Voluntary Reporting Amid Drug Shortages

Law360, New York (February 21, 2012, 4:46 PM EST) -- The U.S. Food and Drug Administration on Tuesday issued detailed guidelines encouraging pharmaceutical and biologics manufacturers to voluntarily report problems that may cause drug shortages, and announced the temporary importation of an unapproved foreign drug to relieve the Doxil shortage.

The FDA also said it had taken steps to avert an impending shortage of methotrexate, a drug used to treat acute lymphocytic leukemia in children, including a fast-track approval of a long-delayed application to make a generic version of the drug. Several hospitals said last week...
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