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Biologics and biosimilars : balancing incentives for innovation : hearing before the Subcommittee on

United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2010. 2010

Drug manufacturing : FDA should fully assess its efforts to encourage innovation : report to congres

United States. Government Accountability Office, author.
Washington, DC : United States Government Accountability Office, 2023. 2023

Follow-on biologics : hearing of the Committee on Health, Education, Labor, and Pensions, United Sta

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

Food and Drug Administration's review process for products to treat rare diseases and neglected trop

United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
Washington : U.S. G.P.O., 2011. 2011

Guidance for industry and FDA current good manufacturing practice for combination products.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2004] 2004

Guidance for industry and FDA staff early development considerations for innovative combination prod

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2006] 2006

Guidance for industry fast track drug development programs, designation, development and application

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, [2006] 2006

Guidance for industry fast track drug development programs, designation, development and application

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, [2004] 2004

Guidance for industry manufacturing, processing, or holding active pharmaceutical ingredients.

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

Guidance for industry PAT, a framework for innovative pharmaceutical development, manufacturing, and

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry population pharmacokinetics.

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, [1999] 1999

Guidance for industry Q3A impurities in new drug substances.

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, [2008] 2008

Guidance for industry Q3B(R2) impurities in new drug products.

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 Q8(R2) pharmaceutical development.

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, [2009] 2009

Guidance for industry quality systems approach to pharmaceutical CGMP regulations.

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

Guidance for industry street drug alternatives.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000] 2000