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

Heparin Crisis Leads To New FDA Policy On Consulting Outside Experts

This article was originally published in The Pink Sheet Daily

Executive Summary

A Government Accountability Office report criticizing FDA's retention of outside experts on heparin contamination spurs disclosure and conflict-of-interest screening policies for emergency situations.

You may also be interested in...



Heparin Crisis Spurs Changes In FDA Emergency Response Policies

Internal and external evaluations of FDA’s handling of the heparin contamination crisis two years ago have led to changes in the agency’s emergency response strategy and a new policy on emergency collaborations with outside experts.

Heparin Crisis Spurs Changes In FDA Emergency Response Policies

Internal and external evaluations of FDA’s handling of the heparin contamination crisis two years ago have led to changes in the agency’s emergency response strategy and a new policy on emergency collaborations with outside experts.

Amphastar Lawsuit Over Heparin Shipments Suggests Lovenox ANDA Approval May Be Far Off

Allegations in Amphastar Pharmaceuticals’ lawsuit over FDA detention of heparin raw ingredient shipments suggest approval of its enoxaparin ANDA, the generic of Sanofi-Aventis’ low-molecular weight heparin Lovenox, is far from imminent.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071543

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