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.”

Read the full article.

Close
Feedback

Disclaimer

Unsolicited e-mails and information sent to Morrison & Foerster will not be considered confidential, may be disclosed to others pursuant to our Privacy Policy, may not receive a response, and do not create an attorney-client relationship with Morrison & Foerster. If you are not already a client of Morrison & Foerster, do not include any confidential information in this message. Also, please note that our attorneys do not seek to practice law in any jurisdiction in which they are not properly authorized to do so.