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Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

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The Food and Drug Administration (FDA) held a 2-day public hearing to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives (collectively "firms"), regarding FDA-regulated drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively, "medical products"). FDA 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. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Meeting Date: 

November 9 - 10, 2016
9:00 AM to 5:00 PM

Meeting Location: 

Food and Drug Administration (FDA)
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Background Information:

Archived Webcast:

Links to the webcast for November 9th:

1. https://collaboration.fda.gov/p8hwtpvbhf5/
2. https://collaboration.fda.gov/p6aidjevntx/
3. https://collaboration.fda.gov/p2fk387o96m/
4. https://collaboration.fda.gov/p8ykl81kx9i/

Links to the webcast for November 10th:

1. https://collaboration.fda.gov/p1dzfhy1bwz/
2. https://collaboration.fda.gov/p5ntock4run/
3. https://collaboration.fda.gov/p2f7bu2rmcg/
4. https://collaboration.fda.gov/p5qnrhxq52a/

Written Comments:

Regardless of attendance at the public meeting, you can submit electronic or written comments to the public docket by January 9, 2017. 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-2016-N-1149. We may post, without change, all comments received to http://www.regulations.gov, including any personal information provided.

UPDATE: FDA has decided to reopen the comment period for 90 days, until April 19, 2017. Interested persons can submit electronic or written comments to the public docket by that date following the instructions above.

Transcripts:

 

 

Page Last Updated: 01/25/2017
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