Pink Sheet 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

Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says

Executive Summary

As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.

You may also be interested in...



US FDA’s Coronavirus Workload Shifting Beyond Idea Stage

Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.

COVID-19 Therapeutics: US FDA Wants Sponsors To Use The Pre-IND Route, Not The Pre-EUA Path

Providing information in a pre-IND meeting request will facilitate a more efficient development process, agency says in a new guidance; generally, there is insufficient information to assess if and when an emergency use authorization might be appropriate when a sponsor first enters discussions with the FDA.

Trump’s ‘Warp Speed’ Initiative Could Fund 3 to 5 Large-Scale COVID Vaccine Trials

FDA’s Peter Marks and Janet Woodcock will be on the bridge for Operation Warp Speed; Moncef Slaoui says early clinical data on one vaccine candidate makes him confident that a few hundred million doses of a vaccine can be available by the end of the year.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS141966

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