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


Hagan Introduces Long-Anticipated TREAT Act, Sans Progressive, Exceptional Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

Bill looks to expand accelerated approval rather than create new approval pathways, and also would reform conflict of interest rules for FDA advisory committees.

You may also be interested in...

Inspection Fees Face Tough Road In Congress As PhRMA Remains Opposed

At user fee hearing, PhRMA’s Wheadon counters questions from Rep. Dingell, saying FDA already is receiving resources to conduct GMP inspections outside the U.S.

FDA Conflict Of Interest Policy May Be Biggest Conflict Of PDUFA Reauthorization

Commissioner Hamburg says the agency likely does not need legislation to improve its conflict of interest policy, but House members still say system needs reform.

Accelerated Approval Could Expand As Alternative To Progressive Approval

CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.

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