FDA Softens 'Dear Doctor' Letter Guidance For Drugmakers

Law360, New York (July 9, 2013, 8:04 PM EDT) -- The U.S. Food and Drug Administration backed down Tuesday from its recommendation that drugmakers evaluate the impact of their letters alerting physicians to new safety information about a drug, after manufacturers complained the request was too burdensome.

The FDA released draft guidance in November 2010 that advised drugmakers when and how to send so-called dear doctor letters, which are used to alert health care professionals to previously unknown adverse reactions linked to a drug, changes in dosage that could improve a drug's effectiveness and other important...
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