Administrative/Regulatory
Feb. 25, 2017
FDA changes regulations on what info manufacturers can share
In response to the legal challenges and industry concerns, the FDA has issued guidance that effectively permit manufacturers to communicate more information about their products than they have before. By David Kirman and Aaron Shapiro
The Food and Drug Administration regulates what pharmaceutical and medical device manufacturers may say when promoting their products. In general, manufacturers must carefully adhere to the FDA-approved labeling or "label." The FDA considers information not contained on the FDA-approved label "off-label." Promoting products "off-label" could violate FDA laws or regulations. To avoid such violations, companies ty...
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