May 14, 2012 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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