News & Updates

24 March 2022

FDA Launches New 24/7 Drug Entry Review Pilot

Author: Anna Cesar – Manager, Regulatory Compliance EMEA

From March 13, 2022, through June 13, 2022, the Food and Drug Administration’s Office of Regulatory Affairs’ Office of Enforcement and Import Operations (OEIO) will run a new entry review pilot.

The pilot has been developed as a way to improve their operational efficiency on account of the continuous increase on FDA regulated imports. This 90-day pilot aims to maximize their entry review staff during peak periods.

The plan is to run all entry admissibility reviews on a national basis versus the current port-by-port entry review approach, utilizing entry review staff over multiple time zones, increasing coverage to 24 hours a day, 7 days a week. The change will allow for an increased response time of all drug entries.

During the pilot, the OEIO will be looking into potential parts of the review process that can be automated, as well as determining if, allowing additional documentation to be provided at the time of the entry, instead of the Documents Requested communications, would result in any efficiency gain – a process being called The More We Know, The Faster You Go.

All feedback and data collected from the pilot will be used to support the OEIO in potential changes to their entry review process.

Please contact our Marken team at if you have any questions, or view the original source here.

Marken Logo

Understanding why we must adapt, continuously asking ourselves how we can change what matters is how we keep on delivering it.