Daily Archives: January 27, 2017


FDA releases draft guidance on off-label communications.

The U.S. Food and Drug Administration has issued the highly anticipated draft guidance to drug makers on how they may communicate with physicians about off-label use of products. The guidance offers a number of ways that manufacturers can share truthful and non-misleading information-and still meet the FDA’s definition of being consistent with a brand’s FDA approved labeling. Examples include:             How a product performs in specific sub-groups within it’s approved patient population             Data about long term safety and efficacy of products treating a chronic condition             Updates from head to head trials with drugs for the same indication and […]