HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Denies Petition Seeking Freeze On Russian Companies’ Regulatory Activities

Executive Summary

Agency tells former OOPD director Tim Coté it doesn't have the authority to consider sponsor’s country of origin when determining whether to act on applications. Despite the denial of petition, FDA continues to support Ukraine.

You may also be interested in...



Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.

Biotech CEOs Take Assertive Stance On Ukraine War, While PhRMA Remains More Neutral

PhRMA wants to ensure medicines remain available, as many smaller companies and other stakeholders call for ‘disengagement’ from Russia.

Sputnik COVID-19 Vaccine Caught Up In Sanctions On Russia Over Ukraine Invasion

As Russia intensifies its invasion of Ukraine with missile attacks and a convoy of armored vehicles, the funder and promoter of the country’s COVID-19 vaccine, Sputnik V, has found itself the subject of punitive international sanctions alongside Russia’s Central Bank.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

RS152890

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel