As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding "Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products." The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of drugs and medical devices, manufacturer statements about off-label use, and the First Amendment.
According to FDA, the agency is engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area.
While registration for the meeting is closed at this time, FDA will post a link to the archived webcast here approximately one week after the public meeting. Regardless of attendance at the public meeting, electronic comments to the public docket may be submitted here by January 9, 2017.
This article is presented for informational purposes only and is not intended to constitute legal advice.
