Would Not Require Collaboration by the Drug Sponsor; FDA Requests Comments on Potential Approach -

The Food and Drug Administration (FDA) requests comment on a potential approval pathway for “ devices referencing drugs” (DRDs). Comments may be submitted until January 15, 2018.

A DRD is a device that would be expressly labeled for use with an approved, marketed drug product outside the scope of the approved drug labeling (e.g., a device labeled for use in the localized injection of a drug product that has otherwise been approved only for intravenous administration, or the use of a device to deliver a drug to a new site or for a new indication). In this scenario, the drug and device product sponsors would not be collaborating, and the drug labeling would not be modified.

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