In The News

FDA Postpones Foreign Inspections Over COVID-19, Potentially Throwing Off Product Approval Timelines

MedCity News

11 Mar 2020

Bethany Hills spoke to MedCity News about the FDA’s policy to postpone foreign inspections over COVID-19, which could impact the timelines of overseas drugmakers who are hoping to get FDA approval.

“If you have an application pending right now, this is definitely on your mind,” Bethany said. “If you don’t have an application pending, strategically you may be thinking about whether or not to hold it because you may create some uncertainty,” which could become problematic if the postponement is extended beyond April, both for the companies’ commercial plans, as well as for the FDA itself. “These are timelines that become strictly adhered to for commercialization and rollouts.”

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