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ndltd-NEU--neu-cj82r79002021-04-13T05:13:59ZRole of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)The inclusion of the patients voice when developing regulatory policy is a burgeoning area of policy practice. The influence of patient advocacy organizations and individual patients on the formation of science-based regulatory policy at the Food and Drug Administration (FDA) has increased dramatically in recent years. In turn, FDAs reliance on external stakeholders, particularly patient advocacy groups has also gained momentum. However, despite enhanced engagement between FDA and patient advocacy stakeholders, there remain challenges to achieving the policy goals of patients within FDA's regulatory framework. Gaps exist between stakeholder knowledge of the policy process and FDA's need for clinically meaningful scientific data, and the process by which patient-based scientific data is used by FDA is still under development.http://hdl.handle.net/2047/D20280899
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The inclusion of the patients voice when developing regulatory policy is a burgeoning area of policy practice. The influence of patient advocacy organizations and individual patients on the formation of science-based regulatory policy at the Food and Drug Administration (FDA) has increased dramatically in recent years. In turn, FDAs reliance on external stakeholders, particularly patient advocacy groups has also gained momentum. However, despite enhanced engagement between FDA and patient advocacy stakeholders, there remain challenges to achieving the policy goals of patients within FDA's regulatory framework. Gaps exist between stakeholder knowledge of the policy process and FDA's need for clinically meaningful scientific data, and the process by which patient-based scientific data is used by FDA is still under development.
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Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)
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| spellingShingle |
Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)
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| title_short |
Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)
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| title_full |
Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)
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| title_fullStr |
Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)
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| title_full_unstemmed |
Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)
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| title_sort |
role of patient advocacy stakeholders in science-based regulatory policy at the u.s. food and drug administration (fda)
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http://hdl.handle.net/2047/D20280899
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1719395704400510976
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