FDA Releases Final Guidance on “Dear Doctor” Letters That Omits Controversial Behavior Modification Assessment Provision

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On January 22, 2014, the FDA issued finalized guidance on the use, content and form of Dear Health Care Provider (DHCP) letters.  While the finalized guidance modifies and removes certain controversial provisions from the November 2010 draft guidance that called for manufacturers to conduct assessments of the impact of some DHCP letters, the finalized guidance retains an expansive definition of the health care providers who should receive such communications.

 


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