This draft guidance describes the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on recommended practices for drug manufacturers (firms) and their representatives to follow if they choose to distribute to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs marketed in the United States. The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling.


The recommendations in this draft guidance are intended to apply to distribution of new risk information (as that term is further explained in section II of this document) for drugs intended for human and animal use. Throughout this draft guidance, the Agency provides references to regulations and guidances specific to drugs intended for human use. Unless otherwise indicated, the Agency generally takes a similar approach when addressing the issues raised in this draft guidance as they pertain to animal drugs. 


Posted on the FDA website on 6 June 2014