In response to increasing import volumes, including through e-commerce, the Food and Drug Administration has developed a pilot project to maximize its entry review staff at periods of highest volume drug entries.

During the pilot, which will run from March 13 through June 13, the FDA will conduct entry admissibility reviews on a national basis versus the current port-by-port approach. The pilot will utilize entry review staff over multiple time zones, allowing the FDA to expand to 24/7 drug entry review coverage at all 336 ports of entry.

The pilot will also (1) examine the potential to automate portions of the entry review process, which would allow entry reviewers to focus more of their time on potentially higher violation products, and (2) help the FDA determine if efficiencies can be gained by receiving associated documentation at the time the entry is made rather than waiting for regular “documents requested” communications.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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