The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

Author:

Levitan Bennett,Hauber A. Brett,Damiano Marina G.,Jaffe Ross,Christopher StephanieORCID

Funder

None

Publisher

Springer Science and Business Media LLC

Reference29 articles.

1. Dialogue/advancing meaningful patient engagement in research, development, and review of drugs. National Health Council & Genetic Alliance; 2015. http://www.nationalhealthcouncil.org/sites/default/files/PatientEngagement-WhitePaper.pdf . Accessed 19 July 2017.

2. Key considerations in developing and integrating patient perspectives in drug development: examination of the Duchenne case study. Biotechnology Innovation Organization; 2016. https://www.bio.org/sites/default/files/BIO_PPMD_whitepaper_web.pdf . Accessed 27 Dec 2016.

3. A framework for incorporating information on patient preferences regarding benefit and risk into regulatory assessment of new medical technology. Medical Device Innovation Consortium; 2015. http://mdic.org/framework-report/ . Accessed 20 Dec 2016.

4. Ho MP, Gonzalez JM, Lerner HP, et al. Incorporating patient-preference evidence into regulatory decision making. Surg Endosc. 2015;29(10):2984–93.

5. Guidance for industry and food and drug administration staff: factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications. US Food and Drug Administration; 2016. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm517504.pdf . Accessed 17 Mar 2017.

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