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FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative

The FDA launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative in 2020 to strengthen the response to the COVID-19 pandemic and resiliency for future public health emergencies. To help achieve these goals, the agency asked an independent, non-government organization to conduct an objective review of the FDA’s pandemic response, inventory accomplishments and activities, and identify future opportunities for consideration. The independent organization interviewed FDA leadership, conducted listening sessions with external stakeholder groups, and collaborated with subject matter experts on the FDA staff to produce the summary report.

The report consists of an Executive Summary and detailed Technical Report summarizing the FDA’s progress and potential actions to consider going forward. While the report is not a to-do list, the FDA carefully reviewed the options while taking into account its current statutory authorities and available resources. Five areas have been identified for our initial focus; the first one includes two options folded into one:

  • Reviewing aspects of the EUA processes for medical products and identifying areas for potential improvement. The objective is to ensure transparency and facilitate appropriate integration of these products including diagnostics, therapeutics and vaccines, into medical care;
  • Reviewing science-based communications to ensure the agency continues to provide timely and accurate communications to the public;
  • Evaluating inspectional approaches using next-gen assessment technologies, such as virtual and video-enabled platforms, to further inspectional reach; and
  • Evaluating the current supply chain tracking, monitoring and assessment systems to identify gaps and challenges, to help stakeholders improve supply chain resilience.

While our response to the COVID-19 public health emergency is an agency priority, we are also committed to strengthening the agency’s public health infrastructure and building the resilience needed to prevent, detect and respond to any emergency.

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