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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

Demonstration of comparability of human biological products, incuding therapeutic biotechnology-der

Rockville, MD : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [1996] 1996

Guidance for industry characterization and qualification of cell substrates and other biological sta

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006] 2006

Guidance for industry container and closure system integrity testing in lieu of sterility testing as

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, [2008] 2008

Guidance for industry IND meetings for human drugs and biologics, chemistry, manufacturing, and cont

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, [2001] 2001

Guidance for industry providing clinical evidence of effectiveness for human drug and biological pro

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