Public Health Regulatory Systems Strengthening - U01 Clinical Trials Not Allowed

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The purpose of the Public Health Regulatory Systems Strengthening NOFO is to partner with the Organization for Economic Co-Operation and Development (OECD), primarily to address the growing threat of illicit trade in health products (drugs, vaccines, medical devices, food) through the development of a whole-of-governments approach that relies on targeted, risk based, and efficient data driven models. The data will be used to develop mitigation strategies and potential regulatory and enforcement solutions that address substandard, misleading, and falsified food and medical products sold both in informal markets and through legitimate channels and raise the profile and awareness of this issue within the global community. The proposed cooperative agreement will also include work on other FDA public health topics of interest, including, but not limited to, addressing mis- and dis-information; strengthening regulatory frameworks by advancing health equity; promoting the use of good regulatory practices to develop regulations that are efficient, transparent, modern, and based on science and risk principles; and enhancing patient engagements in product development and quality of care.

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