BIO presentation at FDA public meeting on biosimilars

May 14, 2012 8:30 AM


Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products.

The key issues she discussed included: interchangeability; naming and labeling; confidentiality of information; reference product and non-U.S. data; patent certification; transition products; and guidence for the implementation of BPCIA.

The full presentation can be reached from here:

The meeting was held last Friday and the transcripts of the public hearing will be available for review at the Division of Dockets Management and on the internet at http://www.regulations.gov approximately 30 days after the public hearing.

 

Source: Biotechnology Industry Organization (BIO)

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