Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C.Format: [electronic resource] :
Publisher: Washington : U.S. G.P.O.,
Date: 2011. This title can be found in 1 Iowa libraries.
Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C.Publisher: Washington : U.S. G.P.O. :
Date: 2011. This title can be found in 1 Iowa libraries.
Biologics and biosimilars balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009.Format: [electronic resource] :
Publisher: Washington : U.S. G.P.O.,
Date: 2010. This title can be found in 1 Iowa libraries.
Biologics and biosimilars : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009.Publisher: Washington : U.S. G.P.O. :
Date: 2010. This title can be found in 1 Iowa libraries.
Guidance for industry Q8(R2) pharmaceutical development.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry Q3A impurities in new drug substances.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2008] This title can be found in 2 Iowa libraries.
Q8(R1) pharmaceutical development revision 1Format: [electronic resource].
Publisher: [Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: 2008?] This title can be found in 1 Iowa libraries.
Follow-on biologics hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007.Format: [electronic resource] :
Publisher: Washington : U.S. G.P.O.,
Date: 2008. This title can be found in 1 Iowa libraries.
Guidance for industry and FDA staff early development considerations for innovative combination products.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products,
Date: [2006] This title can be found in 2 Iowa libraries.
Guidance for industry Q3B(R2) impurities in new drug products.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
Date: [2006] This title can be found in 2 Iowa libraries.
Guidance for industry quality systems approach to pharmaceutical CGMP regulations.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2006] This title can be found in 1 Iowa libraries.
Guidance for industry fast track drug development programs, designation, development and application review.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2006] This title can be found in 2 Iowa libraries.
Guidance PET drug products, current good manufacturing practice (CGMP).Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2005] This title can be found in 1 Iowa libraries.
Guidance for industry PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2004] This title can be found in 1 Iowa libraries.
Guidance for industry and FDA current good manufacturing practice for combination products.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products,
Date: [2004] This title can be found in 2 Iowa libraries.
Guidance for industry fast track drug development programs, designation, development and application review.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2004] This title can be found in 1 Iowa libraries.
Guidance for industry street drug alternatives.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2000] This title can be found in 1 Iowa libraries.
Guidance for industry population pharmacokinetics.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [1999] This title can be found in 1 Iowa libraries.
Guidance for industry manufacturing, processing, or holding active pharmaceutical ingredients.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [1998] This title can be found in 1 Iowa libraries.
Conflict of interest, protection of public ownership, in drug development deals between tax-exempt, federally supported labs and the pharmaceutical industry : hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, first session.Publisher: Washington : For sale by the U.S. G.P.O., Supt. of Docs., Congressional Sales Office,
Date: 1993- This title can be found in 1 Iowa libraries.
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