FDA to Hold Public Hearing on May 11th, 2012 to Obtain Input on Draft Biosimilars Guidance

By: David Fazzolare

The Food and Drug Administration (FDA) plans to hold a public hearing on May 11, 2012, from 8:30 a.m. to 5 p.m., to gather feedback on its recently released draft biosimilars guidance documents.  The FDA’s release of the draft guidance documents is a significant milestone toward the implementation of the Biologics Price Competition and Innovation Act of 2009, which establishes an abbreviated path for the approval of biologic products that are biosimilar to, or interchangeable with, a reference product.  The FDA plans to finalize these draft guidance documents based on the information it receives during the hearing.

Individuals wishing to comment on the FDA’s draft biosimilars guidance may present at the hearing if they register by April 11, 2012, and may submit written comments until May 1, 2012.

The hearing will take place at the FDA’s White Oak Campus, which is located at 10903 New Hampshire Avenue, Building 31, Room 1503, in Silver Spring, Maryland.  The FDA is broadcasting a live webcast of the hearing for those who are unable to attend.  In addition, transcripts will become available no sooner than 30 days after the hearing.

Please review the FDA’s notice, or contact David A. Fazzolare for more information.

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