Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Fast Track Pathway May Be ‘Poor Man’s Breakthrough’ But It Works

Executive Summary

Most requests for the FDA’s less-heralded expedited review designation are based on Phase II or earlier data, and have a greater chance of success than requests for breakthrough designation.

You may also be interested in...



Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval

Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.

Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

Topics

UsernamePublicRestriction

Register

PS141744

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