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11 March 2020

The FDA Adjusts Operations in Response to Coronavirus Concerns

Written by Liz Bloss

As the impact of the coronavirus (COVID-19) continues to spread, FDA is making some adjustments to its operations in the face of the global public health emergency.

Specifically, some scheduled meetings between sponsors and Review Divisions that were originally planned to take place face-to-face have been switched to teleconferences or videoconferences. Furthermore, those who do visit FDA campuses and buildings may be asked questions related to recent international travel.  In one instance last week, one of our clients was specifically informed that people attending a F2F meeting from outside the US would not be allowed to enter the FDA buildings. This meeting, involving a TBG consultant, has now been switched to a t-con.

While the dynamics of meetings held via teleconference/videoconference are significantly different from those that are face-to-face meetings, these kinds of meetings can be managed very successfully with experience and good preparation.

Furthermore, on Tuesday, March 10th, the FDA announced on announced on their website that they are postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

Please find the latest from the FDA on this subject here.

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