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


What Makes a "Breakthrough" Therapy? FDA Says More Details Are Coming

This article was originally published in RPM Report

Executive Summary

FDA’s Janet Woodcock believes the agency will be able to provide more concrete parameters around what constitutes a “Breakthrough” product in its final guidance document on the agency’s expedited programs. Maybe that will help lower the rate of denials.

You may also be interested in...

Covering Breakthroughs: Payors in New Territory

FDA has granted more than two dozen “Breakthrough Therapy” designations. Not everyone is sure that’s a great thing. Payors, in particular, are getting “nervous” about what hyperfast development of hyper-expensive therapies will mean.

FDA Issues Wave Of "Breakthrough Therapy" Denials

FDA denied 10 requests for breakthrough therapy within a four-week period. The reasons behind the wave of rejections are unclear, but may be inherent to the rollout of the program.

US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot

ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.





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