FDA’s Pandemic Recovery and Preparedness Plan

by | Apr 16, 2021 | COVID-19, EUA, FDA, Medical Devices, Regulatory

On April 2nd, 2021, the FDA provided an update on its Pandemic Preparedness and Recovery Plan (PREPP) Initiative. The initiative evaluated FDA’s response to the pandemic by an independent third-party reviewing agency that published a summary report outlining recommendations for improvements.

FDA’s Acting Commissioner Janet Woodcock, M.D. said “As we continue our COVID-19 response, it is critical that we learn from both our successes and the challenges we experienced, to best improve our operations”.1

The Agency has identified five areas for improvement stemming from the PREPP summary report, which are based on the priorities in front of the FDA at the moment, the workload, and the budget. The following are the five areas:1

  • Assessing the current EUA process and improving it to ensure transparency and appropriate integration of products (this area counts as two key opportunities for improvement)
  • Reviewing science-based information to keep the public informed in a timely and accurate manner.
  • Using newer and better technology such as virtual inspection and video-enabled platforms to further FDA’s inspectional reach.
  • Assess the current supply chain tracking mechanisms to monitor and identify gaps to help the industry in improving the supply chain.

Other steps that the FDA may pursue longer-term include partnerships with other US government agencies such as the CDC, NIH and utilizing real-world data for monitoring the post-market performance of COVID-19 related products authorized under a EUA.1

The FDA believes that these steps will help implement a robust public health infrastructure and ensure an efficient response to emergencies in the future. A strategy like this was long overdue and I am sure the industry is looking forward to a more predictable regulatory framework to help get their products to market in these uncertain times.

EMMA International can assist you with all your compliance needs. Call us today at 248-987-4497 or email us at info@emmainternatiional.com.

1FDA (2021) FDA In Brief: FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative retrieved on 04/11/2021 from https://www.fda.gov/news-events/fda-brief/fda-brief-fda-provides-update-covid-19-pandemic-recovery-and-preparedness-plan-initiative

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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