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

Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House

Executive Summary

The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.

You may also be interested in...



Right-To-Try Bill Heads To White House, Putting Firms In Driver's Seat

Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.

'Right-To-Try' Has US FDA Support: Scaled-Back House Bill Retains Agency Oversight

Commissioner Gottlieb’s recent remarks on pending federal 'Right-to-Try' legislation were his most positive to date; he pushed back on earlier versions that would have removed FDA from process. 

US FDA's Label Updating Effort Needs Legislation To Impact Generics

Generic labels can't easily be changed if reference product is withdrawn, meaning legislative fix is needed to add current recommendations to outdated labels.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121258

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