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
UsernamePublicRestriction

GDUFA Timetable Unclear, But Negotiations Will Begin With Lots Of Agreement - Except For Mylan

This article was originally published in The Pink Sheet Daily

Executive Summary

Coalition and GPhA expect to be on the same page at FDA public meeting, but Mylan proposes alternative user fee structure based on establishment fees.

You may also be interested in...



GDUFA Talks: FDA Reminds Industry The Program Is Generic-Only

Generic drug user fee negotiations began with a reminder that components of the program will not apply to other regulated drug sectors.

GDUFA Talks: FDA Reminds Industry The Program Is Generic-Only

Generic drug user fee negotiations began with a reminder that components of the program will not apply to other regulated drug sectors.

GPhA Seeks New Driver As Outgoing VP Johnston Continues To Ford Across User Fee Stream

Among the challenges for the Generic Pharmaceutical Association in its negotiations with FDA over a user fee program will be bringing a new point person up to speed after the departure of Gordon Johnston.

Related Content

Topics

UsernamePublicRestriction

Register

PS071191

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