FDA seeks comments on off-label use data distribution proposal

03/5/2014 | MedPage Today (free registration)

The FDA will accept comments through May 2 on its draft guidance governing the dissemination of data on off-label uses of drugs and medical devices. The guidance provides a list of requirements companies must satisfy before such information can be distributed to doctors and other parties, including that the data be peer-reviewed and circulated with approved labeling.

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