Benefit–Risk Assessments of Medical Treatments

Author:

Levitan Bennett,DiSantostefano Rachael L.,Evans Scott

Publisher

Wiley

Reference120 articles.

1. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary.Washington DC:Institute of Medicine National Academies Press 2007.

2. FDA.Structured Approach to Benefit–Risk Assessment in Drug Regulatory Decision‐Making. Draft PDUFA V Implementation Plan 2013.www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf(accessed April 25 2019).

3. Incorporating patient-preference evidence into regulatory decision making

4. FDA CDRH.Guidance for Industry and Food and Drug Administration Staff: Patient Preference Information – Voluntary Submission Review in Premarket Approval Applications Humanitarian Device Exemption Applications and De Novo Requests and Inclusion in Decision Summaries and Device Labeling 2016. Silver Spring: FDA.

5. FDA.PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf(accessed April 25 2019).

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