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Volumn 50, Issue 2, 2014, Pages 133-158

The year's new drugs & biologics, 2013: Part II

Author keywords

Biosimilars; Breakthrough therapy designation; Discontinuations and withdrawals; Orphan drugs; Qualified infectious disease products

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; NEW DRUG; ORPHAN DRUG;

EID: 84896094863     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2014.50.2.2122810     Document Type: Review
Times cited : (4)

References (13)
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    • Expediting drug development - The FDA's new "breakthrough therapy" designation
    • Sherman, R.E., Li, J., Shapley, S., Robb, M., Woodcock, J. Expediting drug development - The FDA's new "breakthrough therapy" designation. N Engl J Med 2013, 369(20): 1877-80.
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    • Walker, G. Breakthrough Therapy Designation: A new expedited approval pathway in the U.S. Thomson Reuters Forecast Market Insight, June 14, 2013.
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    • Guidance for industry: Expedited programs for serious conditions - Drugs and biologics (U.S. Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research, June 2013). http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Accessed January 31, 2014.
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    • Mullard, A. Learning from the 2012-2013 class of breakthrough therapies. Nat Rev Drug Discov 2013, 12(12): 891-3.
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    • Working together to address the challenges of rare and neglected diseases
    • Committee on Foreign Affairs, U.S. House of Representatives, June 27, Accessed January 31, 2014
    • Goodman, J.L. Working together to address the challenges of rare and neglected diseases. Testimony before the Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations, Committee on Foreign Affairs, U.S. House of Representatives, June 27, 2013. http://www.fda.gov/ newsevents/testimony/ucm358834.htm. Accessed January 31, 2014.
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    • Onyx deal expected to give Amgen a big boost
    • (U.S. Edition), August 26, Accessed February 3, 2014
    • Onyx deal expected to give Amgen a big boost. Reuters News (U.S. Edition), August 26, 2013. http://www.reuters.com/article/2013/08/26/us-onyx- amgen-idUSBRE97O0ES20130826. Accessed February 3, 2014.
    • (2013) Reuters News


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.