FDA Overhauls 'Dear Doctor' Guidance On Drug Risks
Law360, New York (January 22, 2014, 4:14 PM EST) -- The U.S. Food and Drug Administration on Wednesday finalized guidance on how drugmakers should warn physicians of newly discovered risks, eliminating expectations for tracking the impact of "dear doctor" letters but maintaining that even nonprescribers should be alerted.
In the guidance, FDA officials delivered on a promise last year to remove a controversial provision that would have directed pharmaceutical firms to assess the impact of their letters on health care providers and patients. Instead, regulators softened the provision to merely suggest that assessments be performed for internal company use.
Separately, however, the agency continued to insist that updated warnings be sent...
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