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


Congress Mulls Adding “Economic Growth” To FDA Mission Statement

This article was originally published in The Tan Sheet

Executive Summary

As PDUFA hearings start, Commissioner Hamburg says considering the jobs affected by the approval or denial of an application would be difficult and inappropriate. Rep. Rogers and Sen. Coats author bills to require changing FDA’s mission statement in program renewal.

You may also be interested in...

Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees

The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.

Accelerated Approval Expansion Proposals Pending, But One Needs An Overhaul

ULTRA bill will need changes to gain the support of influential patient group. Meanwhile, BIO is circulating a proposal to make changes to existing regulations.

Supply Chain Security Issues To Emerge During Subcommittee Hearing On PDUFA

Related Content


Latest Headlines
See All



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