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

Biomarker Qualification Costs As Much As Application Review, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency’s cost estimate for implementing 21st Century Cures bill seems in part a call for user fees.

You may also be interested in...



Biomarker Qualification 2.0: Cures Act, User Fees Will Enhance FDA Pathway

US agency will be more 'proactive' in engaging with outside groups interested in using the biomarker qualification process using the new resources and directives of the 21st Century Cures Act and the pending Prescription Drug User Fee Act reauthorization.

Congressional ‘Cures’ Debate Shifts To FDA Funding

House Democrats say FDA will need more money to be able to handle the responsibilities in the draft bill, while the agency worries reviews could slow without more resources.

After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?

Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS078499

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