메뉴 건너뛰기




Volumn 20, Issue 2, 2017, Pages 296-298

Value Assessment in the Regulatory Context

Author keywords

FDA; pharmaceuticals; regulation; value assessment

Indexed keywords

ARTICLE; CLINICAL DECISION MAKING; DRUG CONTROL; DRUG DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; PATIENT PARTICIPATION; PATIENT SAFETY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; BIOMEDICAL TECHNOLOGY ASSESSMENT; DECISION MAKING; DRUG APPROVAL; LEGISLATION AND JURISPRUDENCE; PURCHASING; UNITED STATES;

EID: 85013682770     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2016.11.010     Document Type: Article
Times cited : (5)

References (7)
  • 1
    • 0033549087 scopus 로고    scopus 로고
    • The safety of newly approved medicines: do recent market removals mean there is a problem?
    • [1] Friedman, M.A., Woodcock, J., Lumpkin, M.M., et al. The safety of newly approved medicines: do recent market removals mean there is a problem?. JAMA 281 (1999), 1728–1734.
    • (1999) JAMA , vol.281 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3
  • 3
    • 85013641509 scopus 로고    scopus 로고
    • Expediated Programs for Serious Conditions—Drugs and Biologics
    • US Food and Drug Administration Silver Spring, MD
    • [3] US Food and Drug Administration. Guidance for Industry. Expediated Programs for Serious Conditions—Drugs and Biologics. 2014, US Food and Drug Administration, Silver Spring, MD.
    • (2014)
  • 4
    • 84992391392 scopus 로고    scopus 로고
    • Patient preferences in regulatory benefit-risk assessments: a US perspective
    • [4] Johnson, F.R., Zhou, M., Patient preferences in regulatory benefit-risk assessments: a US perspective. Value Health 19 (2016), 741–745.
    • (2016) Value Health , vol.19 , pp. 741-745
    • Johnson, F.R.1    Zhou, M.2
  • 5
    • 85013664428 scopus 로고    scopus 로고
    • The voice of the patient: a series of reports from FDA's Patient-Focused Drug Development Initiative. Available from: [Accessed July 20, 2016].
    • [5] US Food and Drug Administration. The voice of the patient: a series of reports from FDA's Patient-Focused Drug Development Initiative. 2016. Available from: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm. [Accessed July 20, 2016].
    • (2016)
  • 6
    • 85013667852 scopus 로고    scopus 로고
    • Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making: Draft PDUFA V Implementation Plan—February 2013
    • US Food and Drug Administration Silver Spring, MD
    • [6] US Food and Drug Administration. Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making: Draft PDUFA V Implementation Plan—February 2013. 2013, US Food and Drug Administration, Silver Spring, MD.
    • (2013)
  • 7
    • 84995486943 scopus 로고    scopus 로고
    • A benefit risk analysis approach to capture regulatory decision-making: non-small cell lung cancer
    • [7] Raju, G.K., Gurumurthi, K., Domike, R., et al. A benefit risk analysis approach to capture regulatory decision-making: non-small cell lung cancer. Clin Pharmacol Ther 100 (2016), 672–684.
    • (2016) Clin Pharmacol Ther , vol.100 , pp. 672-684
    • Raju, G.K.1    Gurumurthi, K.2    Domike, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.