Author:
Smith Meredith Y.,Benattia Isma,Strauss Carmit,Bloss Laura,Jiang Qi
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference22 articles.
1. US Food and Drug Administration. Structured approach to benefit-risk assessment in drug regulatory decision-making. Draft PDUFA V implementation plan-February 2013. Fiscal years 2013-2017. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. Accessed October 15, 2016.
2. European Medicines Agency (EMA). Benefit-risk methodology project. Work package 3 report: field tests. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500112088.pdf. Accessed October 15, 2016.
3. Leong J, Salek S, Walker S. Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication. Switzerland: ADIS-Springer International Publishing; 2015.
4. Wolka A, Warner M, Bullok K, Wang J, Radawski C, Noel R. Incorporation of a benefit-risk assessment framework into the Clinical Overview of marketing authorization applications. Therapeutic Innovation & Regulatory Science. 2016;50:130–134.
5. Warner M, Wolka A, Noel R. Implementing benefit-risk assessment for the Periodic Benefit-Risk Evaluation Report. Therapeutic Innovation & Regulatory Science. 2016;50:342–346.
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