Healthcare, Industry News, Medical Devices, Regulatory Affairs

US FDA outlines next steps following COVID-19 PREPP

The US FDA have made an announcement followed by issuing a summary report on findings of a third-party review of the agency’s pandemic response efforts, the PREPP which was undertaken from July to December 2020.

Based on the summary report findings as well as current FDA priorities and responsibilities, the agency will initially focus on five PREPP-related efforts. The first area includes two PREPP recommendations folded into one. These include:

  • 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-generation assessment technologies, such as virtual and video-enabled platforms, to further our inspectional reach.
  • Evaluating the current supply chain tracking, monitoring and assessment systems to identify gaps and challenges to help stakeholders improve supply chain resilience.
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