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A Green Card Is No Longer a “Green Light” – Changes to FDA Security Policy

Changes to FDA Security Policy

If you have been to a meeting at the FDA recently, you may have experienced the roller coaster that is their parking/visitor drop-off policy. There have been so many changes that FDA project managers have taken to including specific instructions in the “Meeting Granted” letter. But the fun doesn’t stop there – this is not the only policy that’s changing as part of new security measures being adopted by the Agency.

We were recently notified that permanent US residents (i.e., “green card” holders) are now considered foreign visitors and must be screened in advance of a visit. This means is that green card holders must now complete and submit the “Foreign Visitor Request” form along with non-US citizens. This form is typically attached to the “Meeting Granted” letter, and must be submitted no later than 2 weeks prior to your meeting date. Failure to do so means you will get to sit in the lobby during your meeting (at least the chairs are reasonably comfy!).

As part of Camargo’s comprehensive meeting preparation, we take care of administrative details such as this, so that you can focus your attention on the bigger stuff.

Contact us to learn more about the many ways Camargo can bring value to your drug development program.


Author: Karen Seta-Aust, PhD, Director of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services