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

FDA ‘Expedited Review’ Would Shave Off Additional Month For Some ‘Breakthrough’ Products

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA appears to be establishing new regulatory paradigm – albeit one that is not laid out in statute officially.

You may also be interested in...



PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications

Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.

FDA Continues To Speed PD-1/L1 Drugs To Market

The four-month review of Merck’s Keytruda for first-line lung cancer is a reminder of how quickly the agency has acted on the immune checkpoint inhibitors.

FDA Outlines “Expedited” Review For Breakthrough Therapies; “Hyper-Fast” Reviews, Beyond Oncology

Oncology drug sponsors have gotten used to a “faster-than-Priority” timeline for breakthrough products. Now, FDA is outlining a formal process for its reviewers to use for any “Breakthrough” designated therapy with life-saving potential.

Related Content

Topics

UsernamePublicRestriction

Register

PS078351

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