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  4. Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars - 03/09/2020 - 03/09/2020
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Meeting

Event Title
Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars
March 9, 2020


Date:
March 9, 2020
Time:
9:00 AM - 5:00 PM ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Organized By:

The Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), is announcing a public workshop on March 9, 2020, "FDA/FTC Workshop on a Competitive Marketplace for Biosimilars."  The purpose of the public workshop is to discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace. 

The entrance for public meeting participants (non-FDA employees or contractors) is through Building 1, where routine security check procedures will be performed. For parking, security and other visitor information, please refer to Public Meetings at the FDA White Oak Campus.

Registration

Please use Eventbrite to register for in-person or webcast attendance.

Background Information

  • Federal Register Notice
  • Meeting Agenda - A full agenda will be available approximately 1 week before the meeting.

If you need special accommodations due to a disability, please contact Sandra Benton at 301-796-1042 or sandra.benton@fda.hhs.gov at least 7 days before the workshop.

Webcast Information

This meeting will be available for online viewing, on the day of the meeting via the following link:  FDA/FTC Workshop on a Competitive Marketplace for Biosimilars. If you have used Connect Pro before, test your connection at Meeting Connection Diagnostic. To get a quick overview of the Connect Pro program, visit Adobe Connect Pro Overview.

Public Docket

In addition to providing input at the public workshop, stakeholders are invited to submit electronic or written comments to the public docket. Please review the Federal Register notice for information on submitting comments.  The public docket will close on April 9, 2020. 

Requests for Oral Presentations

For those interested in participating as an Open Public Workshop speaker, please register at Eventbrite as “In-person Open Public Workshop presenter.”  Open Public Workshop registrations are due by February 24, 2020; however, if time is available, you may sign up as an Open Public Workshop speaker the day of the meeting.  Time and space are limited and available on a first-come, first-served basis.  Open Public Workshop speakers may be assigned no more than 5 minutes for their presentation and will deliver oral testimony only (no accompanying slide deck).  No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Questions

Office of Therapeutic Biologics and Biosimilars
Office of New Drugs
Center for Drug Evaluation and Research
CDER-BiologicsBiosimilarsInquiries@fda.hhs.gov