Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

GPhA Warns FDA On ANDA Review Transparency

This article was originally published in The Pink Sheet Daily

Executive Summary

User fee negotiations could be 'lengthy and very detailed' unless FDA does 'the right thing' and implements 'effective' communication practices, generic trade group says.

You may also be interested in...



Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

GDUFA Stakeholder Deadline May Come After Negotiations Conclude

Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS078804

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