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

User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments

Executive Summary

Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.

You may also be interested in...



A Pivotal September For US FDA And Commissioner Califf

The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.

US FDA User Fee Legislation: Is Sen. Burr’s ‘Clean’ Bill A Lifeline – Or A Wrench In The Works?

Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.

A Bipartisan Case Against US FDA User Fees?

Senators Richard Burr and Bernie Sanders do not typically agree on many issues. But during consideration of the US FDA user fee reauthorization package, both expressed concern that the increasing fees contribute to higher drug prices – and both voted against moving the package forward.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146328

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