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

Young US FDA Office Of New Drug Policy Faces Regulatory Crucible In COVID-19

Executive Summary

Created last year under the Office of New Drugs reorganization, ONDP works to promote regulatory consistency while fostering innovation – and reacting to unexpected challenges like the pandemic.

You may also be interested in...



CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System

Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.

US FDA Integrated Assessment Roll-Out Expanding By End Of 2021

All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.

US FDA’s RTOR Program Produces Approvals About One Month Sooner Than Priority Review Goal

Novel agents approved under Real-Time Oncology Review posted a median time to approval of seven months, our Pink Sheet RTOR infographic shows, while other RTOR applications had a median 4.5 month approval time.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS143190

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