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

US FDA To Sponsors: No Dice On Appealing Advice Through Dispute Resolution

Executive Summary

Appeals pathway remains unavailable for challenging regulatory advice on drug and biologic product development programs despite objections from industry; sponsors may approach a higher management level to further discuss such advice in meetings established under the user fee programs, final guidance states.

You may also be interested in...



PTC To Appeal Translarna's Complete Response Letter From US FDA

PTC Therapeutics appears to be hoping that CDER Director Woodcock will do for ataluren what she did for Sarepta's exon-skipping Duchenne muscular dystrophy treatment Exondys 51 since dispute resolution request would first go to Office of New Drugs, where Woodcock is acting director.

Exondys Revisited? Translarna Brings Efficacy Woes Into US Panel Review

FDA has twice refused to file PTC Therapeutics' NDA for the Duchenne muscular dystrophy treatment because of 'clearly and convincingly negative' pivotal trials and questionable post hoc analyses; sponsor argues ataluren should be afforded the same consideration and flexibility given to Sarepta's DMD drug eteplirsen, which received a controversial accelerated approval.

FDA Reverses Position On Fabre-Kramer's Gepirone, Clearing Way For Approval

Dispute resolution win means focus for antidepressant Travivo (gepirone extended-release) shifts to labeling, post-marketing and manufacturing despite going 2 for 12 in clinical trials.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121906

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