EMA responds to Ombudsman questioning of AbbVie trial redactions

13 November 2014

The European Medicines Agency says it has taken note of the European Ombudsman’s recent remarks on the Agency’s redaction of certain documents submitted by a pharmaceutical company, ie, the USA’s AbbVie (NYSE: ABBV).

The Ombudsman is referring to an individual request for documents received and addressed by the Agency to the satisfaction of the requester in early 2014. A detailed reply to the European Ombudsman’s queries will follow in due course, the EMA stated.

Precedent may have been established

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK