Following the Pandemic Recovery and Preparedness Plan (PREPP) summary report, FDA announced the areas it would act on first. Based on the summary report findings as well as current FDA priorities and responsibilities, the agency said it would 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 the agency’s inspectional reach.
- Evaluating the current supply chain tracking, monitoring and assessment systems to identify gaps and challenges to help stakeholders improve supply chain resilience.
For regulatory and quality teams, the lasting effects have been in remote and hybrid inspection practice and in supply-chain expectations. Vakula Tech’s regulatory affairs consultants track these developments for clients.