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21st Century Cures Act : report of the Committee on Energy and Commerce, House of Representatives (t

United States. Congress. House. Committee on Energy and Commerce, author.
[Washington, D.C.] : [U.S. Government Publishing Office], [2015]- 2015

Drug truths : dispelling the myths about pharma R&D

LaMattina, John L.
Hoboken, N.J. : John Wiley & Sons, c2009. 2009

FDA fast track and priority review programs

Thaul, Susan, author.
[Washington, D.C.] : Congressional Research Service, 2018- 2018

Federal taxation of the drug industry and its effects on new drug development

Guenther, Gary L., author.
[Washington, D.C.] : Congressional Research Service, 2019- 2019

Food and Drug Administration's Critical Path Initiative : hearing before a subcommittee of the Commi

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. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

Guidance for industry and review staff recommended approaches to integration of genetic toxicology s

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 acute bacterial otitis media, developing drugs for treatment.

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

Guidance for industry acute bacterial sinusitis, developing drugs for treatment.

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

Guidance for industry bioanalytical method validation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2001] 2001

Guidance for industry extended release oral dosage forms, development, evaluation, and application o

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. [1997] 1997

Maximizing the impact of the Cures Acceleration Network : accelerating the development of new drugs

Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, issuing body.
Washington, District of Columbia : National Academies Press, [2012] 2012

National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 :

United States. Congress. House. Committee on Energy and Commerce, author.
[Washington, D.C.] : [U.S. Government Publishing Office], [2021] 2021

New drug development science, business, regulatory, and intellectual property issues cited as hamper

United States. Government Accountability Office.
[Washington, D.C.] : U.S. Government Accountability Office, [2006] 2006

Patents and regulatory exclusivities: issues in pharmaceutical innovation and competition

Thomas, John R., 1967- author.
[Washington, D.C.] : Congressional Research Service, [2018?]- 2018