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


FDA Amendments Act: More Regulation = More Comfort and More Products

This article was originally published in RPM Report

Executive Summary

Pharma companies are beginning to go to the financial community with an odd message: the companies are delighted to be getting more regulation from the Food & Drug Administration. The reason: the companies see a regulatory environment becoming ever more cautious and risk averse. The only solution is to make FDA more confidence about its decisions. The companies believe more regulatory authority for FDA on safety issues will make for a more confident and predictable regulatory agency.

You may also be interested in...

Kaiser Pushes Back on REMS: Acorda Listens; Will FDA?

Kaiser recognizes that some sponsors are trying to use REMS to make an end-run around gatekeepers, and it is fighting back. The non-profit integrated care system wants FDA to help, filing a citizen petition that could profoundly affect commercialization of new products in the US. The recently approved MS drug Ampyra offers a case-in-point.

Novartis Pediatric Post-Market Plans For Xolair Fall Short Of FDA Request

A post-market program designed by Novartis to control Xolair (omalizumab) in the 6-11 pediatric population was not adequate to convince FDA or its Pulmonary-Allergy Drugs Advisory Committee to extend the indication for use in moderate to severe allergy/asthma patients below 12 years of age

Genentech Aborts Raptiva Amidst Reports Of Fatal Brain Infection

Risk management program couldn't save psoriasis drug. Decision is final, firm says.

Related Content


Related Companies

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