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

Bullet Train: US FDA User Fee Bill Is On Fast Track In House

Executive Summary

The House Energy & Commerce Committee is moving rapidly to complete work on a bipartisan reauthorization of the US FDA’s user fee programs – and it isn’t waiting for any riders that aren’t ready on time. For now, at least, that means the CURES 2.0 bill will have to find another track.

You may also be interested in...



US FDA and ARPA-H: Woodcock Has Questions

The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.

Patient Data In Drug Reviews Would Be Encouraged In Proposed Amendment To User Fee Bill

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

Inactive Ingredient Disclosure Expansion In House User Fee Bill Poised For Changes

Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.

Topics

UsernamePublicRestriction

Register

PS146172

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