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

PDUFA Draft Bill Would Broaden FDA’s Mission, Make Guidance Development More Public

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA would be tasked with protecting public health while promoting economic growth and job creation under a discussion draft from the House authorizing committee. Draft Guidances would be voided if not finalized within a year under the proposal.

You may also be interested in...



User Fee Bills: After Mark-ups, How Will House And Senate Reconcile Differences?

House and Senate committee user fee bill mark-ups approaching, but drafts have differences in drug shortage, supply chain security and other proposed policy changes to reconcile.

Generic User Fee Waivers Dropped In Latest House Draft Bill

Provision allowing generic drug fee waivers in shortage situations was removed in new House user fee draft, but proposals for a new antibacterial approval pathway and breakthrough designation were not included.

Drug Shortage Senate Draft: FDA Told To Look For Impact Before Leaping Into Enforcement

Proposal would require shortage consideration before FDA issues an enforcement action, which could ensure enforcement and shortage staff continue talking.

Related Content

Latest News
UsernamePublicRestriction

Register

PS073877

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