Devices Referencing Drugs; Public Hearing; Request for Comments
- November 16, 2017
- November 16, 2017
The Food and Drug Administration is holding a public hearing on a potential approach for certain device sponsors to seek marketing authorization for a device labeled for use with a drug that is already approved and on the market, when the drug sponsor does not wish to pursue the new use. Called devices referencing drugs (DRDs), these products have the potential to advance public health by offering new uses with approved, marketed drugs that might not otherwise be available.
FDA, in cooperation with the Drug Information Association, held a public meeting in 2005 on combined uses of separately distributed products and other related issues. FDA has since gained greater experience with DRDs and is seeking comment on a potential approach for addressing the unique public health, scientific, regulatory, and legal issues that these products may raise.
Hearing Date and Time
November 16, 2017
9 a.m. to 5 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
the Great Room (Rm. 1503, Section A)
Silver Spring, MD 20993-0002
The entrance for public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.
- Federal Register notice
- Agenda (PDF - 25KB)
- Information from the 2005 FDA/DIA Cross Labeling Workshop (Archived)
- Public Hearing Presentations
- Meeting Trancript
If you wish to attend the public hearing (either in person or by webcast) and/or present at the hearing, please register by October 26, 2017.
FDA will provide a free-of-charge live webcast for viewing the public hearing. We will post a link to the archived webcast on this page approximately one week after the hearing. A written transcript of the hearing will be made available in the public docket.
FDA will try to accommodate all persons who wish to make a presentation. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak. Once FDA notifies registered presenters of their scheduled times, they are encouraged to submit an electronic copy of their presentation to firstname.lastname@example.org on or before November 2, 2017.
If you need special accommodations because of a disability, please contact the Office of Combination Products at 301-796-8930 or email@example.com at least 7 days before the hearing.
ALERT: CHANGE TO COMMENT PERIOD
In light of recent requests received for additional time, FDA published a notice in the Federal Register to provide stakeholders an additional 30 days to submit comments. You can submit electronic or written comments to the public docket by February 21, 2018. The docket number and link remain the same.
Regardless of attendance at the public hearing, you can submit electronic or written comments to the public docket by January 15, 2018. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments must be identified with the docket number FDA-2017-N-5319. We may post, without change, all comments received to http://www.regulations.gov, including any personal information provided.
If you have questions about registering for the hearing, contact the Office of Combination Products, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, phone: 301-796-8930, fax: 301-847-8619, email: firstname.lastname@example.org.