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Assessing the impact of a safe and equitable biosimilar policy in the United States hearing before t

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

Guidance for industry manufacturing biological intermediates and biological drug substances using sp

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2007] 2007

Guidance for industry Q5A viral safety evaluation of biotechnology products derived from cell lines

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1998] 1998

Safe and affordable biotech drugs : the need for a generic pathway : hearing before the Committee on

United States. Congress. House. Committee on Oversight and Government Reform.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008