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U.S. Department of Health and Human Services

Drugs

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Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments

The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on recently issued draft guidances relating to the development of biosimilar products (draft guidances).  These draft guidances were issued by FDA as part of the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  The BPCI Act establishes an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, a reference product.  FDA will consider the information it obtains from the public hearing in the finalization of these guidances.  In addition, FDA is soliciting public input regarding topics for future policies regarding biosimilars.

Date:        May 11, 2012

Time:        8:30 a.m. to 5:30 p.m.

Location:  FDA White Oak Campus
                 Great Room
                 Building 31, Room 1503
                10903 New Hampshire Avenue
                Silver Spring, MD 20993

Visitor Information

All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)

Webcast of Meeting

For those unable to attend in person, the meeting will also be webcast. Watch the webcast on May 11 from 8:30 am to 5:00 pm. Requirements and instructions for accessing the webcast are below.

Access to the webcast are available via this link:

Adobe Connect Minimum Requirements

  • View meetings on Windows, Macs, Unix, and Linux platforms
  • Lan or Broadband internet connection
  • Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
  • Adobe Flash Player (no other downloads needed)
  • VPN and Parachute compatible but not required
  • Test my computer for Adobe Connect-Readiness

Attendance and Registration to Speak

The FDA Conference Center at the White Oak location is a federal facility with limited seating so attendance will be on a first come-first served basis. 

Individuals who wish to speak must register by sending an e-mail to biosimilarspublicmtg@fda.hhs.gov on or before April 11, 2012 and provide complete contact information for each speaker, including name, title, affiliation, address, e-mail, and phone number.  FDA will do its best to accommodate requests to speak and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.

If you need special accommodations because of disability, please contact Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, phone (301)796-1042, e-mail biosimilarspublicmtg@fda.hhs.gov at least 7 days before the meeting.