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


FDA Prepares For Issues for Treatment of Parenteral Nutrition Associated Liver Disease

This article was originally published in RPM Report

Executive Summary

FDA is planning an advisory committee discussion of the “need for and design of” clinical trials for parenteral nutrition products in the US. The panel was scheduled for October 15 but was cancelled for logistical reasons. The discussion is likely to build on a September public workshop that wrestled with the unique challenges in developing new formulations of vital supportive therapies. In this article, an executive with one of the firms with different parenteral products outside the US (Fresenius/Kabi) outlines the issues raised in the workshop and the reaction of expert panelists.

You may also be interested in...

The Impact of REMS on Generic Drug Approvals and Drug Competition

From the conception of the REMS in the FDAAA Act of 2007, Congress was concerned that giving FDA authority to impose new post-marketing controls could raise competitive issues about market access for generics. Congress was right to be concerned. Despite a specific admonition in FDAAA to prevent use of the most restrictive REMS programs to prevent new competition, strategies to extend product exclusivity have emerged and the competitive landscape has changed.


Related Companies




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